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2024

Guidelines for clinical evaluation of chronic kidney disease in early stages : AMED research on regulatory science of pharmaceuticals and medical devices.
Sugawara Y, Kanda E, Hamano T, Itano S, Okada H, Tomori K, Watanabe Y, Asakura W, Isaka Y, Iseki K, Usui T, Suzuki Y, Tanaka M, Nishimura R, Fukami K, Matsushita K, Wada J, Watada H, Ueki K, Kashihara N, Nangaku M.
Clin Exp Nephrol. 2024. Epub 20240706.
https://doi.org/10.1007/s10157-024-02514-6. PMID: 38970650

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan.
Kuribayashi R, Goto K, Hariu A, Kishioka Y.
Expert Opin Biol Ther. 2024. Epub 20240706.
https://doi.org/10.1080/14712598.2024.2377300. PMID: 38970459

Risk of neutropenia in psoriasis patients prescribed anti-IL-23 antibody in comparison with anti-IL-17 antibody or adalimumab based on real-world data from the MID-NET in Japan.
Okada Y, Kajiyama K, Ishiguro C, Nonaka T, Komaki T, Kuga W, Komiyama N, Iguchi T, Horiuchi N, Uyama Y.
J Dermatolog Treat. 2024; 35(1): 2373826. Epub 20240704.
https://doi.org/10.1080/09546634.2024.2373826. PMID: 38964751

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, Chen G, Cristofoletti R, Dallmann A, Delvadia P, Dressman J, Fotaki N, Gray E, Heimbach T, Holte Ø, Kijima S, Kotzagiorgis E, Lennernäs H, Lindahl A, Loebenberg R, Mackie C, Malamatari M, McAllister M, Mitra A, Moody R, Mudie D, Musuamba Tshinanu F, Polli JE, Rege B, Ren X, Rullo G, Scherholz M, Song I, Stillhart C, Suarez-Sharp S, Tannergren C, Tsakalozou E, Veerasingham S, Wagner C, Seo P.
Mol Pharm. 2024. Epub 20240630.
https://doi.org/10.1021/acs.molpharmaceut.4c00526. PMID: 38946085

Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC).
Matsumoto M, Polli JR, Swaminathan SK, Datta K, Kampershroer C, Fortin MC, Salian-Mehta S, Dave R, Yang Z, Arora P, Hiura M, Suzuki M, Brennan FR, Sathish J.
Clin Pharmacol Ther. 2024. Epub 20240607.
https://doi.org/10.1002/cpt.3316. PMID: 38847597

Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines.
Singh R, Wang W, Chakravarty A, Wang J, Uyama Y.
Ther Innov Regul Sci. 2024. Epub 20240512.
https://doi.org/10.1007/s43441-024-00639-0. PMID: 38736019

Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.
Garot P, Morice MC, Angiolillo DJ, Cabau JR, Park DW, Van Mieghem NM, Collet JP, Leon MB, Sengottuvelu G, Neylon A, Ten Berg JM, Mylotte D, Tchétché D, Krucoff MW, Reardon MJ, Piazza N, Mack MJ, Généreux P, Makkar R, Hayashida K, Ohno Y, Mochizuki S, Shirai Y, Matsumara R, Jin Y, Webb JG, Cutlip DE, Chen M, Spitzer E, Mehran R, Capodanno D.
EuroIntervention. 2024; 20(9): 536-50.
https://doi.org/10.4244/eij-d-23-01020. PMID: 38726720

Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database.
Iwata R, Mochizuki S, Hasegawa T, Ishii K, Matsumaru N, Tsukamoto K.
Ther Innov Regul Sci. 2024. Epub 20240506.
https://doi.org/10.1007/s43441-024-00660-3. PMID: 38710990

Disease progression modeling with temporal realignment: An emerging approach to deepen knowledge on chronic diseases.
Yoshioka H, Jin R, Hisaka A, Suzuki H.
Pharmacol Ther. 2024; 259: 108655. Epub 20240504.
https://doi.org/10.1016/j.pharmthera.2024.108655. PMID: 38710372

Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.
Kuribayashi R, Hariu A, Nakano A, Kishioka Y.
Pharmaceut Med. 2024; 38(3): 225-39. Epub 20240429.
https://doi.org/10.1007/s40290-024-00525-y. PMID: 38684588

ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup.
Bourcier T, McGovern T, Cavaliero T, Ebere G, Nishikawa A, Nishimura J, Ogawa K, Pasanen M, Vespa A, Van der Laan JW.
Front Toxicol. 2024; 6: 1353783. Epub 20240411.
https://doi.org/10.3389/ftox.2024.1353783. PMID: 38665214

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.
Tanaka Y, Tanaka M, Miyazawa H, Terashima R, Miyazawa M, Ikuma M, Tomita Y.
Clin Transl Sci. 2024; 17(4): e13803.
https://doi.org/10.1111/cts.13803. PMID: 38651283

Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET) in Japan.
Tanigawa M, Kohama M, Hirata K, Izukura R, Kandabashi T, Kataoka Y, Nakashima N, Kimura M, Uyama Y, Yokoi H.
Ther Innov Regul Sci. 2024. Epub 20240421.
https://doi.org/10.1007/s43441-024-00619-4. PMID: 38644459

Guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance in Japan: A tiered approach for the assessment of clinically meaningful driving impairment.
Nakabayashi T, Iwamoto K, Yamaguchi A, Konishi Y, Saji M, Yoshimura R, Kanemoto K, Aoki H, Ando M, Ozaki N.
Neuropsychopharmacol Rep. 2024. Epub 20240416.
https://doi.org/10.1002/npr2.12436. PMID: 38624143

Increased risk of hypocalcemia with decreased kidney function in patients prescribed bisphosphonates based on real-world data from the MID-NET in Japan: a new-user cohort study.
Hasegawa T, Komamine M, Ishiguro C, Motomura H, Kajiyama K, Nonaka T, Nakazato Y, Kimura R, Maniwa H, Iguchi T, Horiuchi N, Uyama Y.
BMC Nephrol. 2024; 25(1): 134. Epub 20240415.
https://doi.org/10.1186/s12882-024-03553-7. PMID: 38622507

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, Polli JE, Rullo G.
Mol Pharm. 2024; 21(5): 2065-80. Epub 20240410.
https://doi.org/10.1021/acs.molpharmaceut.4c00202. PMID: 38600804

The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.
Fernandes EAF, van Oudtshoorn J, Tam A, González LCA, Aurela EG, Potthast H, Mettke K, Kuribayashi R, Shimojo K, Kasuga M, Morales L, Rodríguez Z, Jones B, Ahn C, Yun E, Kim SH, Rodrigues C, Tiong T, Crane C, Walther C, Roost MS, Chen TL, Hsu LF, Braddy AC, García-Arieta A, Abalos I, Divinsky M, Alsuwyeh A, Alzenaidy B, Alharf A.
J Pharm Pharm Sci. 2024; 27: 12398. Epub 20240321.
https://doi.org/10.3389/jpps.2024.12398. PMID: 38577255

Different Development Strategies Affecting Japan's Drug lag between Japan-Based and Foreign-Based Companies.
Hidaka M, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2024. Epub 20240404.
https://doi.org/10.1007/s43441-024-00649-y. PMID: 38575785

Genistein Enhances TRAIL-Mediated Apoptosis Through the Inhibition of XIAP and DcR1 in Colon Carcinoma Cells Treated with 5-Fluorouracil.
Çal Doğan T, Aydın Dilsiz S, Canpınar H, Ündeğer Bucurgat Ü.
Turk J Pharm Sci. 2024; 21(1): 7-24.
https://doi.org/10.4274/tjps.galenos.2023.60543. PMID: 38528786

Lower Dose of 5 mL of 1% Lidocaine is More Suitable than the Conventional 10 mL for Caudal Block in Transrectal Prostate Biopsy: A Retrospective Cohort Study.
Ueda N, Sato M, Mori S, Matsukawa A, Oki Y, Kujime Y, Mizuno R, Horitani H, Yamamoto T, Fukae S, Yoshinaga M, Matsushita M, Akiyama M, Kamido S, Honda A, Nakayama J, Tei N, Miyake O.
Adv Urol. 2024; 2024: 9331738. Epub 20240214.
https://doi.org/10.1155/2024/9331738. PMID: 38389652

Prescription trend and lactic acidosis in patients prescribed metformin before and after the revision of package insert for allowing metformin administration to patients with moderately decreased kidney function based on real-world data from MID-NET in Japan.
Waki T, Okada Y, Kinoshita Y, Kajiyama K, Ishiguro C, Nakazato Y, Kimura R, Maniwa H, Horiuchi N, Iguchi T, Uyama Y.
Front Med (Lausanne). 2023; 10: 1294696. Epub 20240124.
https://doi.org/10.3389/fmed.2023.1294696. PMID: 38327270

Real-world prescription of anti-COVID-19 drugs in hospitalized patients with COVID-19 in Japan.
Shida H, Komamine M, Kajiyama K, Waki T, Maruyama H, Uyama Y.
PLoS One. 2024; 19(1): e0297679. Epub 20240126.
https://doi.org/10.1371/journal.pone.0297679. PMID: 38277429

Summary Report of a Public Workshop: Case Studies of Multi-Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline.
Matsushima N, Otsubo Y, Aoi Y, Nakamura R, Kaneko S, Asakawa T, Matsuoka N, Watabe K, Komiyama O, Yamamoto H, Ando Y.
Clin Pharmacol Ther. 2024; 115(5): 965-70. Epub 20240122.
https://doi.org/10.1002/cpt.3163. PMID: 38251824

2023

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics.
Ait-Oudhia S, Wang YM, Dosne AG, Roy A, Jin JY, Shen J, Kagan L, Musuamba FT, Zhang L, Kijima S, Gastonguay MR, Ouellet D.
Clin Pharmacol Ther. 2024; 115(3): 412-21. Epub 20231218.
https://doi.org/10.1002/cpt.3133. PMID: 38069528

Dealing with missing data in laboratory test results used as a baseline covariate: results of multi-hospital cohort studies utilizing a database system contributing to MID-NET in Japan.
Komamine M, Fujimura Y, Omiya M, Sato T.
BMC Med Inform Decis Mak. 2023; 23(1): 242. Epub 20231030.
https://doi.org/10.1186/s12911-023-02345-7. PMID: 37904196

Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET in Japan.
Hasegawa T, Sawada S, Saito T, Kohama M, Kajiyama K, Ishiguro C, Nonaka T, Okamura T, Iwasaki Y, Ueda T, Iguchi T, Horiuchi N, Uyama Y.
Ther Innov Regul Sci. 2024; 58(1): 192-9. Epub 20231029.
https://doi.org/10.1007/s43441-023-00586-2. PMID: 37899426

Extracting the latent needs of dementia patients and caregivers from transcribed interviews in japanese: an initial assessment of the availability of morpheme selection as input data with Z-scores in machine learning.
Tanemura N, Sasaki T, Miyamoto R, Watanabe J, Araki M, Sato J, Chiba T.
BMC Med Inform Decis Mak. 2023; 23(1): 203. Epub 20231005.
https://doi.org/10.1186/s12911-023-02303-3. PMID: 37798639

Efficacy and safety of axitinib for metastatic renal cell carcinoma: Real-world data on patients with renal impairment.
Minami K, Osawa T, Kojima T, Hara T, Eto M, Takeuchi A, Nakai Y, Ueda K, Ozawa M, Uemura M, Ohba K, Tamura K, Shindo T, Nakagomi H, Takahashi A, Anai S, Yokomizo A, Morizane S, Kimura T, Shimazui T, Miyauchi Y, Mitsuzuka K, Hara H, Yoshimura K, Shiina H, Ito YM, Murai S, Nishiyama H, Shinohara N, Kitamura H.
Urol Oncol. 2023; 41(11): 458.e9-.e19. Epub 20231003.
https://doi.org/10.1016/j.urolonc.2023.08.008. PMID: 37798145

Effects of Mobilization within 72 h of ICU Admission in Critically Ill Patients: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Matsuoka A, Yoshihiro S, Shida H, Aikawa G, Fujinami Y, Kawamura Y, Nakanishi N, Shimizu M, Watanabe S, Sugimoto K, Taito S, Inoue S.
J Clin Med. 2023; 12(18). Epub 20230911.
https://doi.org/10.3390/jcm12185888. PMID: 37762829

Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.
Hoberman AM, Maki K, Mikashima F, Naota M, Wange RL, Lansita JA, Weis SL.
Int J Toxicol. 2023; 42(6): 467-79. Epub 20230915.
https://doi.org/10.1177/10915818231200859. PMID: 37714565

Updated report of COVID-19 vaccine safety monitoring in Japan: booster doses for Omicron variants and vaccinations for infants and young children.
Yamaguchi T, Iwagami M, Ishiguro C, Kitao S, Tetsuhashi M, Izumi M, Yoshihara S, Kobatake H, Banzai Y, Kinoshita N, Iguchi T, Oka A, Morio T, Nakai K, Hayashi S, Takagi R.
Lancet Reg Health West Pac. 2023; 38: 100885. Epub 20230825.
https://doi.org/10.1016/j.lanwpc.2023.100885. PMID: 37662067

Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan.
Aoi Y, Kato Y, Asano K, Otsubo Y, Uyama Y.
Ther Innov Regul Sci. 2023; 57(6): 1298-303. Epub 20230816.
https://doi.org/10.1007/s43441-023-00566-6. PMID: 37587270

Training the next generation of pharmacometric modelers: a multisector perspective.
Bonate PL, Barrett JS, Ait-Oudhia S, Brundage R, Corrigan B, Duffull S, Gastonguay M, Karlsson MO, Kijima S, Krause A, Lovern M, Riggs MM, Neely M, Ouellet D, Plan EL, Rao GG, Standing J, Wilkins J, Zhu H.
J Pharmacokinet Pharmacodyn. 2024; 51(1): 5-31. Epub 20230813.
https://doi.org/10.1007/s10928-023-09878-4. PMID: 37573528

Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Marshall S, Ahamadi M, Chien J, Iwata D, Farkas P, Filipe A, Frey N, Greene E, Kawai N, Li J, Lippert J, Musuamba Tshinanu F, Manolis E, Peterson MC, Sarem S, Shebley M, Tegenge M, Tsai CH, Tu CL, Otsubo Y, Wei J, Zhang L, Zhu H, Karlsson KE.
Clin Pharmacol Ther. 2023; 114(5): 954-9. Epub 20230803.
https://doi.org/10.1002/cpt.3006. PMID: 37534711

Regulatory Aspects of Cell and Gene Therapy Products: The Japanese Perspective.
Maruyama Y, Noda S, Okudaira S, Sakurai A, Okura N, Honda F.
Adv Exp Med Biol. 2023; 1430: 155-79. Epub 20230802.
https://doi.org/10.1007/978-3-031-34567-8_9. PMID: 37526847

Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium.
Capodanno D, Mehran R, Krucoff MW, Baber U, Bhatt DL, Capranzano P, Collet JP, Cuisset T, De Luca G, De Luca L, Farb A, Franchi F, Gibson CM, Hahn JY, Hong MK, James S, Kastrati A, Kimura T, Lemos PA, Lopes RD, Magee A, Matsumura R, Mochizuki S, O'Donoghue ML, Pereira NL, Rao SV, Rollini F, Shirai Y, Sibbing D, Smits PC, Steg PG, Storey RF, Ten Berg J, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Serruys PW, Yeh RW, Morice MC, Angiolillo DJ.
Circulation. 2023; 147(25): 1933-44. Epub 20230619.
https://doi.org/10.1161/circulationaha.123.064473. PMID: 37335828

Heterogeneity of placebo effects on urinary incontinence in overactive bladder syndrome: A meta-analysis of Japanese placebo-controlled clinical trials.
Hara T.
Int J Urol. 2023; 30(10): 896-905. Epub 20230615.
https://doi.org/10.1111/iju.15226. PMID: 37317904

Insights into the clinical development of regenerative medical products through a comparison of three cell-based products recently approved for limbal stem cell deficiency.
Aketa N, Kasai M, Noda S, Asano J, Kunieda A, Kawanishi S, Maruyama Y, Honda F.
Ocul Surf. 2023; 29: 220-5. Epub 20230529.
https://doi.org/10.1016/j.jtos.2023.05.008. PMID: 37257692

Effect of Neuromuscular Electrical Stimulation in Patients With Critical Illness: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Nakanishi N, Yoshihiro S, Kawamura Y, Aikawa G, Shida H, Shimizu M, Fujinami Y, Matsuoka A, Watanabe S, Taito S, Inoue S.
Crit Care Med. 2023; 51(10): 1386-96. Epub 20230526.
https://doi.org/10.1097/ccm.0000000000005941. PMID: 37232695

Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention.
Okumoto A, Nomura Y, Maki K, Ogawa T, Onodera H, Shikano M, Okabe N.
Regul Toxicol Pharmacol. 2023; 142: 105413. Epub 20230523.
https://doi.org/10.1016/j.yrtph.2023.105413. PMID: 37230176

Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.
Kuribayashi R, Nakano A, Hariu A, Kishioka Y, Honda F.
BioDrugs. 2023; 37(4): 443-51. Epub 20230525.
https://doi.org/10.1007/s40259-023-00605-6. PMID: 37227657

Conditional early approval for new drug applications in Japan: Current and emerging issues.
Tanaka M, Miyazawa H, Terashima R, Ikuma M.
Clin Transl Sci. 2023; 16(8): 1289-93. Epub 20230510.
https://doi.org/10.1111/cts.13536. PMID: 37161871

In vivo CAR T cells and targeted gene delivery: A theme for the Pharmaceuticals and Medical Devices Agency Science Board to address.
Wakao R, Fukaya-Shiba A.
Front Med (Lausanne). 2023; 10: 1141880. Epub 20230417.
https://doi.org/10.3389/fmed.2023.1141880. PMID: 37138754

A new era of the Asian clinical research network: a report from the ATLAS international symposium.
Terada M, Nakamura K, Matsuda T, Okuma HS, Sudo K, Yusof A, Imasa M, Sirachainan E, Anh PT, Fujiwara Y, Yamamoto N, Voon PJ, Chokephaibulkit K, Shibata T, Inoue M, Mano H, Shimoi T, Sriuranpong V, Yonemori K, Shimada K.
Jpn J Clin Oncol. 2023; 53(7): 619-28.
https://doi.org/10.1093/jjco/hyad033. PMID: 37099440

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline.
Iwamoto K, Nakabayashi T, Yamaguchi A, Konishi Y, Saji M, Yoshimura R, Kanemoto K, Aoki H, Ando M, Ozaki N.
Neuropsychopharmacol Rep. 2023; 43(2): 172-6. Epub 20230414.
https://doi.org/10.1002/npr2.12339. PMID: 37057649

Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.
Yasinskaya Y, Bala S, Waack U, Dixon C, Higgins K, Moore JN, Jjingo CJ, O'Shaughnessy E, Colangelo P, Botgros R, Nambiar S, Angulo D, Dane A, Chiller T, Hodges MR, Sandison T, Hope W, Walsh TJ, Pappas P, Katragkou A, Kovanda L, Rex JH, Marr KA, Ostrosky-Zeichner L, Sekine S, Deshpande M, Shukla SJ, Farley J.
Clin Infect Dis. 2023; 77(3): 380-7.
https://doi.org/10.1093/cid/ciad195. PMID: 37021650

Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.
Maruyama Y, Sakurai A, Noda S, Fujiwara Y, Okura N, Takagi T, Asano J, Honda F.
Oncologist. 2023; 28(8): 664-70.
https://doi.org/10.1093/oncolo/oyad041. PMID: 36917020

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan.
Shida H, Kajiyama K, Sawada S, Ishiguro C, Kubo M, Kimura R, Hirano M, Komiyama N, Iguchi T, Oniyama Y, Uyama Y.
Front Med (Lausanne). 2023; 10: 1096992. Epub 20230223.
https://doi.org/10.3389/fmed.2023.1096992. PMID: 36910503

Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.
Iwamoto S, Cavanaugh K, Malone M, Lottes A, Thatcher R, Kumar K, Rowland S, Fearnot N, Uchida T, Iwaishi C, Senshu K, Konishi R, Ikeda K, Suzuki Y, Ikeno F, Tamura A, Ho M, Ohashi M, Katayama H, Krucoff MW.
Cardiovasc Revasc Med. 2023; 52: 67-74. Epub 20230224.
https://doi.org/10.1016/j.carrev.2023.02.015. PMID: 36870799

Practical basket design for binary outcomes with control of family-wise error rate.
Asano J, Sato H, Hirakawa A.
BMC Med Res Methodol. 2023; 23(1): 52. Epub 20230227.
https://doi.org/10.1186/s12874-023-01872-1. PMID: 36849940

A Japanese concept of considerations for evaluation of dental materials for tooth bleaching.
Kurauchi M, Sato Y, Tanishiro H, Morita R, Otsuki M, Kaneko J, Tsubaki T, Yoshida B, Aso K, Murakami M, Kondoh M.
Jpn Dent Sci Rev. 2023; 59: 23-7. Epub 20230207.
https://doi.org/10.1016/j.jdsr.2023.01.001. PMID: 36819743

A meta-analysis on the characteristics of placebo effects on urinary function in placebo-controlled clinical trials among Japanese patients.
Hara T.
Int J Urol. 2023; 30(5): 447-54. Epub 20230214.
https://doi.org/10.1111/iju.15152. PMID: 36788748

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database.
Koseki T, Horie M, Kumazawa S, Nakabayashi T, Yamada S.
Front Psychiatry. 2022; 13: 1091386. Epub 20230109.
https://doi.org/10.3389/fpsyt.2022.1091386. PMID: 36699485

Challenges in Expediting the Development of Oncology Drugs.
Noguchi E, Yaginuma H, Fujiwara Y.
JCO Oncol Pract. 2023; 19(4): 216-7. Epub 20230119.
https://doi.org/10.1200/op.22.00705. PMID: 36657099

Characterizing Granulocytopenia Associated with Thiamazole in Patients with Hyperthyroidism Based on Real-World Data from the MID-NET in Japan.
Kinoshita Y, Kajiyama K, Ishiguro C, Nonaka T, Kimura R, Kikuchi Y, Horiuchi N, Iguchi T, Uyama Y.
Clin Pharmacol Ther. 2023; 113(4): 924-31. Epub 20230131.
https://doi.org/10.1002/cpt.2850. PMID: 36648197

2022

Clinical Practice Guidelines in Cardio-Oncology: A Sea of Opportunity.
Sase K, Mukai M, Fujiwara Y.
JACC CardioOncol. 2023; 5(1): 145-8. Epub 20221206.
https://doi.org/10.1016/j.jaccao.2022.11.001. PMID: 36875908

A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients.
Kojima H, Nakada T, Yagami A, Todo H, Nishimura J, Yagi M, Yamamoto K, Sugiyama M, Ikarashi Y, Sakaguchi H, Yamaguchi M, Hirota M, Aizawa S, Nakagawa S, Hagino S, Hatao M.
Curr Res Toxicol. 2023; 4: 100100. Epub 20221223.
https://doi.org/10.1016/j.crtox.2022.100100. PMID: 36619289

Japanese Pharmaceutical Regulations of Engineered Viral Vectors for Medical Use Compared With Those in the United States and the European Union.
Sakurai A, Kanzaki S, Honda F.
Clin Pharmacol Ther. 2023; 113(5): 960-2. Epub 20221120.
https://doi.org/10.1002/cpt.2788. PMID: 36404404

Synchondrosis fusion contributes to the progression of postnatal craniofacial dysmorphology in syndromic craniosynostosis.
Hoshino Y, Takechi M, Moazen M, Steacy M, Koyabu D, Furutera T, Ninomiya Y, Nuri T, Pauws E, Iseki S.
J Anat. 2023; 242(3): 387-401. Epub 20221117.
https://doi.org/10.1111/joa.13790. PMID: 36394990

Cardiovascular risk of urate-lowering drugs: A study using the National Database of Health Insurance Claims and Specific Health Checkups of Japan.
Sawada S, Kajiyama K, Shida H, Kimura R, Nakazato Y, Iguchi T, Oniyama Y, Ishiguro C, Uyama Y.
Clin Transl Sci. 2023; 16(2): 206-15. Epub 20221111.
https://doi.org/10.1111/cts.13439. PMID: 36317407

Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events.
Kobayashi H, Fukuda S, Matsukawa R, Asakura Y, Kanno Y, Hatta T, Saito Y, Shimizu Y, Kawarasaki S, Kihara M, Kinoshita N, Umeda H, Noda T, Imamura T, Nishioka Y, Yamaguchi T, Hayashi S, Iguchi T.
Ther Innov Regul Sci. 2023; 57(2): 329-42. Epub 20221030.
https://doi.org/10.1007/s43441-022-00466-1. PMID: 36310329

Analysis and enhancement of risk management for ethnic differences in antineoplastic drugs in Japan.
Uzu S, Sato J, Wakao R, Nonaka T.
BMC Health Serv Res. 2022; 22(1): 1292. Epub 20221026.
https://doi.org/10.1186/s12913-022-08685-w. PMID: 36289504

A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme.
Tam A, Garcia-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodriguez Martinez Z, Divinsky M, Kariv R, Potthast H, Braddy AC, Rodrigues C, Guzman Aurela E, Carolina Arevalo Gonzalez L, Gutierres Triana D, Jones B, Ahn C, Kim H, Kim SH, Kuribayashi R, Myoenzono A, Shimojo K, Van Oudtshoorn J, Bigler C, Meincke R, Roost MS, Walther C, Hsu LF, Crane C, Jarman T.
J Pharm Pharm Sci. 2022; 25: 323-39. Epub 20221008.
https://doi.org/10.18433/jpps33081. PMID: 36251699

HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force.
Wang SV, Pottegård A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S, Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ.
Value Health. 2022; 25(10): 1663-72.
https://doi.org/10.1016/j.jval.2022.09.001. PMID: 36241338

HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
Wang SV, Pottegård A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S, Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ.
Pharmacoepidemiol Drug Saf. 2023; 32(1): 44-55. Epub 20221010.
https://doi.org/10.1002/pds.5507. PMID: 36215113

Activity and perspective on quantitative modeling and simulation in Japan: Update from the Pharmaceuticals and Medical Devices Agency.
Kijima S, Yoshida S, Ochiai Y.
CPT Pharmacometrics Syst Pharmacol. 2022; 11(12): 1552-5. Epub 20221005.
https://doi.org/10.1002/psp4.12868. PMID: 36199197

Proposal for the revision of guidelines for clinical trials of vaccines to prevent infectious diseases in Japan.
Nomura Y, Noda K, Oohashi Y, Okuda S, Matsumoto J, Nakano T, Tsuchida N, Ishii KJ, Hayashi K, Iiyama T, Onodera H, Ishii K, Shikano M, Okabe N.
Vaccine. 2022; 40(43): 6295-304. Epub 20220924.
https://doi.org/10.1016/j.vaccine.2022.09.036. PMID: 36167693

Updated report of COVID-19 vaccine safety monitoring in Japan: Booster shots and paediatric vaccinations.
Yamaguchi T, Iwagami M, Ishiguro C, Fujii D, Yamamoto N, Sakai H, Tsuboi T, Umeda H, Kinoshita N, Iguchi T, Oka A, Morio T, Nakai K, Hayashi S, Tsuruta S.
Lancet Reg Health West Pac. 2022; 27: 100600. Epub 20220921.
https://doi.org/10.1016/j.lanwpc.2022.100600. PMID: 36160728

First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA.
Kuribayashi R, Kasuga M, Kuwana K, Yamaguchi T.
Ther Innov Regul Sci. 2023; 57(2): 173-7. Epub 20220913.
https://doi.org/10.1007/s43441-022-00457-2. PMID: 36100793

A doxycycline-inducible CYP3A4-Caco-2 cell line as a model for evaluating safety of aflatoxin B1 in the human intestine.
Bai L, Tachibana K, Murata M, Inoue T, Mizuguchi H, Maeda S, Ikemura K, Okuda M, Kusakabe T, Kondoh M.
Toxicol Lett. 2022; 370: 1-6. Epub 20220912.
https://doi.org/10.1016/j.toxlet.2022.09.005. PMID: 36100150

Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses.
Yamamoto H, Suzuki H.
EClinicalMedicine. 2022; 52: 101601. Epub 20220826.
https://doi.org/10.1016/j.eclinm.2022.101601. PMID: 36059890

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data.
Inuzuka R, Tachimori H, Kim SH, Matsui H, Kobayashi T, Kato A, Fujii T, Ho M, Morikawa H, Takahashi S, Shirato H, Haishima Y, Okamoto Y, Sakoda H, Tomita H.
Circ J. 2022; 86(12): 1990-7. Epub 20220901.
https://doi.org/10.1253/circj.CJ-22-0185. PMID: 36047087

Japanese Regulatory Considerations for Interoperability of Medical Devices.
Ishimoto K, Arafune T, Washio T, Haishima Y, Koichiro M, Uematsu M, Nomura Y, Yokoi H, Sato H, Madoka M, Okazaki Y, Tachibana K, Kondoh M.
Ther Innov Regul Sci. 2023; 57(1): 104-8. Epub 20220822.
https://doi.org/10.1007/s43441-022-00444-7. PMID: 35994203

Clinical characteristics of COVID-19 patients with underlying rheumatic diseases in Japan: data from a multicenter observational study using the COVID-19 Global Rheumatology Alliance physician-reported registry.
Kihara M, Sugihara T, Asano J, Sato M, Kaneko H, Muraoka S, Ohshima S, Nanki T.
Clin Rheumatol. 2022; 41(12): 3661-73. Epub 20220816.
https://doi.org/10.1007/s10067-022-06305-w. PMID: 35974224

Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016-2019.
Kohama M, Nonaka T, Uyama Y, Ishiguro C.
Ther Innov Regul Sci. 2023; 57(1): 37-47. Epub 20220813.
https://doi.org/10.1007/s43441-022-00437-6. PMID: 35963930

Reliance is key to effective access and oversight of medical products in case of public health emergencies.
Saint-Raymond A, Valentin M, Nakashima N, Orphanos N, Santos G, Balkamos G, Azatyan S.
Expert Rev Clin Pharmacol. 2022; 15(7): 805-10. Epub 20220809.
https://doi.org/10.1080/17512433.2022.2088503. PMID: 35945703

Assessment of bone health in patients with prostate cancer using cancer staging computed tomography.
Sato M, Kashii M, Matsukawa A, Mizuno R, Akiyama M, Kamatani T, Kamido S, Ueda N, Nakayama J, Tei N, Yoshikawa H, Miyake O.
J Bone Miner Metab. 2022; 40(4): 648-56. Epub 20220512.
https://doi.org/10.1007/s00774-022-01328-4. PMID: 35546371

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Bhatnagar V, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gormley N, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Kwong YL, Little RF, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Nair A, Nastoupil L, Robertson K, Sidana S, Smedby KE, Sonneveld P, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Seymour JF, Habermann TM.
Lancet Haematol. 2022; 9(5): e374-e84.
https://doi.org/10.1016/s2352-3026(22)00045-x. PMID: 35483398

Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.
Epps C, Bax R, Croker A, Green D, Gropman A, Klein AV, Landry H, Pariser A, Rosenman M, Sakiyama M, Sato J, Sen K, Stone M, Takeuchi F, Davis JM.
Ther Innov Regul Sci. 2022; 56(6): 964-75. Epub 20220426.
https://doi.org/10.1007/s43441-022-00409-w. PMID: 35471559

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Wadhwa M, Kang HN, Thorpe R, Knezevic I, Aprea P, Bielsky MC, Ekman N, Heim HK, Joung J, Kurki P, Lacana E, Njue C, Nkansah E, Savkina M, Thorpe R, Yamaguchi T, Wadhwa M, Wang J, Weise M, Wolff-Holz E.
Biologicals. 2022; 76: 1-9. Epub 20220422.
https://doi.org/10.1016/j.biologicals.2022.03.001. PMID: 35466023

Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET Medical Information Database Network in Japan.
Hasegawa T, Sawada S, Ishiguro C, Ando T, Kobayashi K, Komiyama N, Iguchi T, Nonaka T, Uyama Y.
Ther Innov Regul Sci. 2022; 56(4): 625-31. Epub 20220418.
https://doi.org/10.1007/s43441-022-00400-5. PMID: 35437631

Safety monitoring of COVID-19 vaccines in Japan.
Yamaguchi T, Iwagami M, Ishiguro C, Fujii D, Yamamoto N, Narisawa M, Tsuboi T, Umeda H, Kinoshita N, Iguchi T, Noda T, Tsuruta S, Oka A, Morio T, Nakai K, Hayashi S.
Lancet Reg Health West Pac. 2022; 23: 100442. Epub 20220329.
https://doi.org/10.1016/j.lanwpc.2022.100442. PMID: 35359913

Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan.
Nomura Y, Noda K, Oohashi Y, Okuda S, Maki K, Ogawa T, Nakano T, Tsuchida N, Ishii KJ, Hayashi K, Iiyama T, Onodera H, Ishii K, Shikano M, Okabe N.
Vaccine. 2022; 40(19): 2810-8. Epub 20220324.
https://doi.org/10.1016/j.vaccine.2022.03.043. PMID: 35341649

Early Treatment with Sotrovimab for Covid-19.
Fujiwara Y.
N Engl J Med. 2022; 386(15): 1480-1. Epub 20220316.
https://doi.org/10.1056/NEJMc2201606. PMID: 35294998

A Different Case of Penumbra: A Japanese Framework for Safe and Expedited Access to High-risk Medical Devices.
Yamamoto H, Kusakabe T, Takahashi M.
JAMA Intern Med. 2022; 182(5): 569-70.
https://doi.org/10.1001/jamainternmed.2022.0102. PMID: 35285855

Validity of identification algorithms combining diagnostic codes with other measures for acute ischemic stroke in MID-NET.
Tanigawa M, Kohama M, Nonaka T, Saito A, Tamiya A, Nomura H, Kataoka Y, Okauchi M, Tamiya T, Inoue R, Nakayama M, Suzuki T, Uyama Y, Yokoi H.
Pharmacoepidemiol Drug Saf. 2022; 31(5): 524-33. Epub 20220309.
https://doi.org/10.1002/pds.5423. PMID: 35224801

Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia.
Noguchi A, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2022; 56(3): 523-9. Epub 20220218.
https://doi.org/10.1007/s43441-022-00381-5. PMID: 35181842

Early prognostic impact of serum sodium level among out-of-hospital cardiac arrest patients: a nationwide multicentre observational study in Japan (the JAAM-OHCA registry).
Shida H, Matsuyama T, Komukai S, Irisawa T, Yamada T, Yoshiya K, Park C, Nishimura T, Ishibe T, Yagi Y, Kiguchi T, Kishimoto M, Kim SH, Hayashi Y, Sogabe T, Morooka T, Sakamoto H, Suzuki K, Nakamura F, Nishioka N, Okada Y, Matsui S, Yoshimura S, Kimata S, Kawai S, Makino Y, Iwami T, Kitamura T.
Heart Vessels. 2022; 37(7): 1255-64. Epub 20220119.
https://doi.org/10.1007/s00380-022-02020-3. PMID: 35044522

2021

Clinical Utility of Circulating Tumor DNA in Advanced Rare Cancers.
Okuma HS, Yonemori K, Kojima Y, Tanioka M, Sudo K, Noguchi E, Hijioka S, Wakakuwa K, Kato K, Hirakawa A, Kuchiba A, Kubo T, Ichikawa H, Yoshida A, Yatabe Y, Nakamura K, Mano H, Yamamoto N, Fujiwara Y.
Front Oncol. 2021; 11: 732525. Epub 20211124.
https://doi.org/10.3389/fonc.2021.732525. PMID: 34900683

Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation.
Nakamura K, Ozawa H, Shibata T, Ushirozawa N, Hata T, Okita N, Fuse N, Sato N, Ikeda K, Hanaoka H, Maruyama T, Wada M, Shimizu S, Kasai H, Yamamoto Y, Sakurai J, Todaka K, Tashiro S, Yamamoto H.
Ther Innov Regul Sci. 2022; 56(2): 220-9. Epub 20211117.
https://doi.org/10.1007/s43441-021-00350-4. PMID: 34787814

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.
Fukaya-Shiba A, Otsuka K, Sasaki H, Shikano M, Wakao R.
Front Med (Lausanne). 2021; 8: 756870. Epub 20211011.
https://doi.org/10.3389/fmed.2021.756870. PMID: 34708061

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
Roost MS, Potthast H, Walther C, García-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodríguez Martínez Z, Tam A, Rodrigues C, Gutierrez Triana DA, Guzmán Aurela E, Rodríguez Rodríguez N, Aeh Park S, Kim J, Kariv R, Divinsky M, Jones B, Kuribayashi R, Myoenzono A, Kasuga M, Van Oudtshoorn J, Chi JF, Hung WY, Hsu LF, Crane C, Jarman T, Braddy A.
J Pharm Pharm Sci. 2021; 24: 548-62.
https://doi.org/10.18433/jpps32260. PMID: 34706215

Classification of drugs for evaluating drug interaction in drug development and clinical management.
Maeda K, Hisaka A, Ito K, Ohno Y, Ishiguro A, Sato R, Nagai N.
Drug Metab Pharmacokinet. 2021; 41: 100414. Epub 20210708.
https://doi.org/10.1016/j.dmpk.2021.100414. PMID: 34666290

Nonclinical safety assessment of engineered T cell therapies.
Lebrec H, Maier CC, Maki K, Ponce R, Shenton J, Green S.
Regul Toxicol Pharmacol. 2021; 127: 105064. Epub 20211014.
https://doi.org/10.1016/j.yrtph.2021.105064. PMID: 34656748

Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future.
Kasuga M, Kuribayashi R, Ogawa T, Ugi A, Yamaguchi T, Takagi K, Hirota M.
Eur J Drug Metab Pharmacokinet. 2021; 46(6): 711-9. Epub 20210929.
https://doi.org/10.1007/s13318-021-00720-1. PMID: 34586614

Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan.
Nishioka K, Makimura T, Ishiguro A, Nonaka T, Yamaguchi M, Uyama Y.
Clin Pharmacol Ther. 2022; 111(1): 35-43. Epub 20210918.
https://doi.org/10.1002/cpt.2410. PMID: 34528701

Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: Cooperation toward extracellular vesicle-based products.
Fukaya-Shiba A, Shimokawa M, Sasaki H, Wakao R.
Br J Clin Pharmacol. 2022; 88(3): 1392-4. Epub 20210915.
https://doi.org/10.1111/bcp.15065. PMID: 34528281

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective.
Iwamoto S, Ohashi M, Shirato H, Ho M, Malone M, Cavanaugh K.
Cardiovasc Revasc Med. 2022; 37: 118-9. Epub 20210901.
https://doi.org/10.1016/j.carrev.2021.08.020. PMID: 34483075

Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan.
Tanaka A, Suzuki H, Toyoshima S, Nagai N.
Ther Innov Regul Sci. 2022; 56(1): 85-95. Epub 20210818.
https://doi.org/10.1007/s43441-021-00332-6. PMID: 34406635

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan.
Matsuda T, Ohura N, Mineta K, Ho M, Kaku I, Ishii K, Inoue M, Ichioka S, Tanaka R, Kawamoto A, Terashi H, Kishi K, Kobayashi Y.
J Wound Care. 2021; 30(8): 666-76.
https://doi.org/10.12968/jowc.2021.30.8.666. PMID: 34382845

Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report.
Iguchi T, Umeda H, Kojima M, Kanno Y, Tanaka Y, Kinoshita N, Sato D.
Drug Saf. 2021; 44(11): 1209-14. Epub 20210804.
https://doi.org/10.1007/s40264-021-01104-9. PMID: 34347278

Associations of coprescribed medications for chronic comorbid conditions in very old adults with clinical dementia: a retrospective cohort study using insurance claims data.
Handa N, Mitsutake S, Ishizaki T, Nakabayashi T, Akishita M, Tamiya N, Yoshie S, Iijima K.
BMJ Open. 2021; 11(7): e043768. Epub 20210715.
https://doi.org/10.1136/bmjopen-2020-043768. PMID: 34266835

The PMDA's view on the limited pipeline of nephrology drugs in Japan.
Tanaka M, Ikuma M.
Kidney Int. 2021; 100(1): 241-2.
https://doi.org/10.1016/j.kint.2021.03.034. PMID: 34154711

Assessment of the impact of Japanese-specific long-term safety data on new drug approval.
Uzu S, Sekine S, Asano J, Ikuma M.
Clin Transl Sci. 2021; 14(6): 2339-47. Epub 20210714.
https://doi.org/10.1111/cts.13098. PMID: 34121342

Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis.
Ezaki A, Hirakawa A, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2021; 55(5): 1075-81. Epub 20210609.
https://doi.org/10.1007/s43441-021-00309-5. PMID: 34109567

Characteristics of hospital differences in missing of clinical laboratory test results in a multi-hospital observational database contributing to MID-NET in Japan.
Komamine M, Fujimura Y, Nitta Y, Omiya M, Doi M, Sato T.
BMC Med Inform Decis Mak. 2021; 21(1): 181. Epub 20210606.
https://doi.org/10.1186/s12911-021-01543-5. PMID: 34090442

The PMDA Perspectives on New Oral Prolyl Hydroxylase Domain Enzyme Inhibitors for Renal Anemia.
Tanaka M, Ikuma M, Asakura W, Fujiwara Y.
Clin Pharmacol Ther. 2022; 111(2): 358-61. Epub 20210516.
https://doi.org/10.1002/cpt.2275. PMID: 33993499

Guidelines for clinical evaluation of anti-cancer drugs.
Minami H, Kiyota N, Kimbara S, Ando Y, Shimokata T, Ohtsu A, Fuse N, Kuboki Y, Shimizu T, Yamamoto N, Nishio K, Kawakami Y, Nihira SI, Sase K, Nonaka T, Takahashi H, Komori Y, Kiyohara K.
Cancer Sci. 2021; 112(7): 2563-77. Epub 20210608.
https://doi.org/10.1111/cas.14967. PMID: 33990993

No-fault compensation schemes for COVID-19 medical products.
Fujiwara Y, Onda Y, Hayashi S.
Lancet. 2021; 397(10286): 1707-8.
https://doi.org/10.1016/s0140-6736(21)00784-4. PMID: 33965083

Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma.
Kanno H, Nagata H, Ishiguro A, Tsuzuranuki S, Nakano S, Nonaka T, Kiyohara K, Kimura T, Sugawara A, Okazaki Y, Takae S, Nakabayashi T, Arai H, Suzuki H.
Oncologist. 2021; 26(7): e1250-e5. Epub 20210518.
https://doi.org/10.1002/onco.13805. PMID: 33928712

Nested Case-Control Study Utilizing MID-NET on Thrombocytopenia Associated With Pegfilgrastim in Patients Treated With Antineoplastic Agents.
Kajiyama K, Ishiguro C, Ando T, Kubota Y, Kinoshita N, Oniyama Y, Iguchi T, Uyama Y.
Clin Pharmacol Ther. 2021; 110(2): 473-9. Epub 20210519.
https://doi.org/10.1002/cpt.2263. PMID: 33866559

Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic.
Chong SSF, Kim M, Limoli M, Obscherning E, Wu P, Feisee L, Nakashima N, Lim JCW.
Ther Innov Regul Sci. 2021; 55(4): 786-98. Epub 20210411.
https://doi.org/10.1007/s43441-021-00285-w. PMID: 33840083

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.
Wakao R, Lönnstedt IM, Aoki Y, Chandler RE.
Drug Saf. 2021; 44(6): 681-97. Epub 20210410.
https://doi.org/10.1007/s40264-021-01063-1. PMID: 33837924

Pediatric Medical Devices - Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan.
Miyoshi T, Kato A, Yasukochi S, Takahashi S, Ho M, Yamamoto H, Inuzuka R, Kim SH, Sakamoto K, Kobayashi T.
Circ Rep. 2021; 3(3): 153-60. Epub 20210126.
https://doi.org/10.1253/circrep.CR-20-0136. PMID: 33738348

Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region.
Tanemura N, Sasaki T, Sato J, Urushihara H.
Trials. 2021; 22(1): 204. Epub 20210312.
https://doi.org/10.1186/s13063-021-05143-6. PMID: 33706800

Achievements and challenges of the Sakigake designation system in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. 2021; 87(10): 4027-35. Epub 20210322.
https://doi.org/10.1111/bcp.14807. PMID: 33694268

Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. 2021; 87(8): 3279-91. Epub 20210305.
https://doi.org/10.1111/bcp.14749. PMID: 33511674

Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals.
Hirabayashi Y, Maki K, Kinoshita K, Nakazawa T, Obika S, Naota M, Watanabe K, Suzuki M, Arato T, Fujisaka A, Fueki O, Ito K, Onodera H.
Nucleic Acid Ther. 2021; 31(2): 114-25. Epub 20210119.
https://doi.org/10.1089/nat.2020.0879. PMID: 33470890

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies.
Wang SV, Pinheiro S, Hua W, Arlett P, Uyama Y, Berlin JA, Bartels DB, Kahler KH, Bessette LG, Schneeweiss S.
Bmj. 2021; 372: m4856. Epub 20210112.
https://doi.org/10.1136/bmj.m4856. PMID: 33436424

Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET) in Japan.
Sawada S, Ando T, Hirano M, Komiyama N, Iguchi T, Oniyama Y, Ishiguro C, Uyama Y.
Ther Innov Regul Sci. 2021; 55(3): 539-44. Epub 20210103.
https://doi.org/10.1007/s43441-020-00247-8. PMID: 33393016

Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data.
Sai K, Nakatani E, Iwama Y, Hiraoka S, Tohkin M, Uyama Y, Saito Y.
Ther Innov Regul Sci. 2021; 55(3): 523-38. Epub 20210103.
https://doi.org/10.1007/s43441-020-00246-9. PMID: 33393013

Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.
Hata T, Nakamura K, Yonemori K, Noguchi E, Watanabe M, Sohn J, Lu YS, Yap YS, Tamura K, Fujiwara Y.
Clin Transl Sci. 2021; 14(3): 1015-25. Epub 20210301.
https://doi.org/10.1111/cts.12965. PMID: 33382914

2020

Evaluation of reoperations for removal of bioabsorbable plates and screws based on adverse events reports from PMDA, Japan.
Kobayashi T, Handa N, Koike K, Mochizuki S, Kaku I, Takae S.
BMJ Surg Interv Health Technol. 2020; 2(1): e000033. Epub 20200506.
https://doi.org/10.1136/bmjsit-2020-000033. PMID: 35047790

Control strategy and methods for continuous direct compression processes.
Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, Mano E, Motoyama K, Koide T, Matsui Y, Kurasaki K, Takayama I, Hikage S, Katori N, Kikuchi M, Sakai H, Matsuda Y.
Asian J Pharm Sci. 2021; 16(2): 253-62. Epub 20201208.
https://doi.org/10.1016/j.ajps.2020.11.005. PMID: 33995618

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.
Shimokawa M, Sato D, Wakao R, Arai H.
Clin Pharmacol Ther. 2021; 109(2): 295-8. Epub 20200818.
https://doi.org/10.1002/cpt.1986. PMID: 33469964

Efficacy and safety of second-line axitinib in octogenarians with metastatic renal cell carcinoma.
Nakai Y, Takeuchi A, Osawa T, Kojima T, Hara T, Sugimoto M, Eto M, Minami K, Ueda K, Ozawa M, Uemura M, Miyauchi Y, Ohba K, Kashiwagi A, Murakami M, Sazuka T, Yasumoto H, Morizane S, Kawasaki Y, Morooka D, Shimazui T, Yamamoto Y, Nakagomi H, Tomida R, Ito YM, Murai S, Kitamura H, Nishiyama H, Shinohara N.
J Geriatr Oncol. 2021; 12(5): 834-7. Epub 20201231.
https://doi.org/10.1016/j.jgo.2020.12.012. PMID: 33388281

Reliance: a smarter way of regulating medical products - The IPRP survey.
Doerr P, Valentin M, Nakashima N, Orphanos N, Santos G, Balkamos G, Saint-Raymond A.
Expert Rev Clin Pharmacol. 2021; 14(2): 173-7. Epub 20201223.
https://doi.org/10.1080/17512433.2021.1865798. PMID: 33355025

Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing.
Ishimoto H, Kano M, Sugiyama H, Takeuchi H, Terada K, Aoyama A, Shoda T, Demizu Y, Shimamura J, Yokoyama R, Miyamoto Y, Hasegawa K, Serizawa M, Unosawa K, Osaki K, Asai N, Matsuda Y.
Chem Pharm Bull (Tokyo). 2021; 69(2): 211-7. Epub 20201208.
https://doi.org/10.1248/cpb.c20-00824. PMID: 33298636

Modernization and Strengthening of Bioequivalence Guidelines in Japan.
Kuribayashi R, Yamaguchi T, Takagi K.
Clin Pharmacokinet. 2021; 60(2): 145-51. Epub 20201128.
https://doi.org/10.1007/s40262-020-00965-0. PMID: 33247363

Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan.
Asano K, Aoi Y, Kamada S, Uyama Y, Tohkin M.
Clin Pharmacol Ther. 2021; 109(6): 1555-63. Epub 20201216.
https://doi.org/10.1002/cpt.2121. PMID: 33245786

Regulatory challenges with biosimilars: an update from 20 countries.
Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, Chua HM, Dalili D, Foo F, Gao K, Habahbeh S, Hamel H, Kim GH, Perez Rodriguez V, Putri DE, Rodgers J, Savkina M, Semeniuk O, Srivastava S, Tavares Neto J, Wadhwa M, Yamaguchi T.
Ann N Y Acad Sci. 2021; 1491(1): 42-59. Epub 20201121.
https://doi.org/10.1111/nyas.14522. PMID: 33222245

Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass in adult patients undergoing cardiac surgery.
Asada M, Nagata M, Mizuno T, Uchida T, Takahashi H, Makita K, Arai H, Kijima S, Echizen H, Yasuhara M.
Eur J Clin Pharmacol. 2021; 77(5): 735-45. Epub 20201119.
https://doi.org/10.1007/s00228-020-03045-1. PMID: 33211137

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A.
J Pharm Sci. 2021; 110(2): 594-609. Epub 20201103.
https://doi.org/10.1016/j.xphs.2020.10.059. PMID: 33152375

Maternal DNMT3A-dependent de novo methylation of the paternal genome inhibits gene expression in the early embryo.
Richard Albert J, Au Yeung WK, Toriyama K, Kobayashi H, Hirasawa R, Brind'Amour J, Bogutz A, Sasaki H, Lorincz M.
Nat Commun. 2020; 11(1): 5417. Epub 20201027.
https://doi.org/10.1038/s41467-020-19279-7. PMID: 33110091

A Potential Role of Adhesion Molecules on Lung Metastasis Enhanced by Local Inflammation.
Horiguchi H, Tsujimoto H, Shinomiya N, Matsumoto Y, Sugasawa H, Yamori T, Miyazaki H, Saitoh D, Kishi Y, Ueno H.
Anticancer Res. 2020; 40(11): 6171-8.
https://doi.org/10.21873/anticanres.14637. PMID: 33109554

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States.
Takahashi S, Iwasaki K, Shirato H, Ho M, Umezu M.
J Artif Organs. 2021; 24(1): 90-101. Epub 20201020.
https://doi.org/10.1007/s10047-020-01216-6. PMID: 33079285

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Clin Pharmacol Ther. 2021; 109(5): 1265-73. Epub 20201115.
https://doi.org/10.1002/cpt.2080. PMID: 33048367

Balancing Safety and Efficacy With Early Availability in the Regulation of Regenerative Medicine Product.
Fujiwara Y, Maruyama Y, Honda F.
Clin Pharmacol Ther. 2021; 109(5): 1182-5. Epub 20200926.
https://doi.org/10.1002/cpt.2034. PMID: 32979224

Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan.
Bun S, Yonemori K, Sunadoi H, Nishigaki R, Noguchi E, Okusaka T, Nishida T, Fujiwara Y.
JCO Oncol Pract. 2021; 17(3): e416-e25. Epub 20200921.
https://doi.org/10.1200/op.20.00131. PMID: 32956004

Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel.
Capodanno D, Morice MC, Angiolillo DJ, Bhatt DL, Byrne RA, Colleran R, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock SJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhovel U, Krucoff MW, Urban P, Mehran R.
J Am Coll Cardiol. 2020; 76(12): 1468-83.
https://doi.org/10.1016/j.jacc.2020.06.085. PMID: 32943165

Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan.
Myoenzono A, Kuribayashi R, Yamaguchi T, Ogawa T, Takagi K.
Eur J Drug Metab Pharmacokinet. 2020; 45(6): 697-702.
https://doi.org/10.1007/s13318-020-00646-0. PMID: 32930951

Letter by Kizawa et al Regarding Article, "Aromatase Inhibitors and the Risk of Cardiovascular Outcomes in Women With Breast Cancer: A Population-Based Cohort Study".
Kizawa R, Hara T, Miura Y.
Circulation. 2020; 142(11): e154-e5. Epub 20200914.
https://doi.org/10.1161/circulationaha.120.047232. PMID: 32924570

Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan.
Takamura K, Tachibana K, Kihira T, Nakai K, Tsutsumi Y, Kondoh M.
Ther Innov Regul Sci. 2021; 55(2): 304-8. Epub 20200911.
https://doi.org/10.1007/s43441-020-00215-2. PMID: 32918260

Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan.
Kijima S, Ochiai Y, Ishiguro A.
CPT Pharmacometrics Syst Pharmacol. 2020; 9(10): 550-2. Epub 20200911.
https://doi.org/10.1002/psp4.12554. PMID: 32914930

The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness.
Cocoros NM, Arlett P, Dreyer NA, Ishiguro C, Iyasu S, Sturkenboom M, Zhou W, Toh S.
Clin Pharmacol Ther. 2021; 109(5): 1189-96. Epub 20201008.
https://doi.org/10.1002/cpt.2045. PMID: 32911562

Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems.
Saint-Raymond A, Sato J, Kishioka Y, Teixeira T, Hasslboeck C, Kweder SL.
Expert Rev Clin Pharmacol. 2020; 13(10): 1095-101. Epub 20200929.
https://doi.org/10.1080/17512433.2020.1821650. PMID: 32909843

Role of Roxadustat for ESA-Resistant Renal Anemia? -Read with Caution.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. 2020; 31(11): 2737. Epub 20200904.
https://doi.org/10.1681/asn.2020060821. PMID: 32897870

Optimization of the quality by design approach for gene therapy products: A case study for adeno-associated viral vectors.
Tanaka T, Hanaoka H, Sakurai S.
Eur J Pharm Biopharm. 2020; 155: 88-102. Epub 20200809.
https://doi.org/10.1016/j.ejpb.2020.08.002. PMID: 32784043

A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations.
Asano J, Hirakawa A.
Pharm Stat. 2020; 19(6): 975-1000. Epub 20200810.
https://doi.org/10.1002/pst.2049. PMID: 32779393

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint.
Mitsutake Y, Konishi A, Shiba T, Ito T, Ho M, Shirato H.
Heart Vessels. 2021; 36(2): 155-62. Epub 20200810.
https://doi.org/10.1007/s00380-020-01676-z. PMID: 32776235

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan.
Yamaguchi T, Uchida E, Okada T, Ozawa K, Onodera M, Kume A, Shimada T, Takahashi S, Tani K, Nasu Y, Mashimo T, Mizuguchi H, Mitani K, Maki K.
Hum Gene Ther. 2020; 31(19-20): 1043-53. Epub 20200917.
https://doi.org/10.1089/hum.2020.156. PMID: 32731837

Scientific considerations for global drug development.
Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN, Lee HA, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, Lumpkin MM, Giacomini KM, Blaschke TF.
Sci Transl Med. 2020; 12(554).
https://doi.org/10.1126/scitranslmed.aax2550. PMID: 32727913

Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan.
Tanemura N, Sasaki T, Sato J, Urushihara H.
Patient. 2020; 13(5): 623-32.
https://doi.org/10.1007/s40271-020-00436-5. PMID: 32725324

Rare cancers in Japan: definition, clinical features and future perspectives.
Kawai A, Higashi T, Shibata T, Yoshida A, Katoh Y, Fujiwara Y, Nishida T.
Jpn J Clin Oncol. 2020; 50(9): 970-5.
https://doi.org/10.1093/jjco/hyaa121. PMID: 32719865

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System.
Mitsutake Y, Konishi A, Handa N, Ho M, Shirato H, Ito T, Koike K, Mochizuki S, Ishii K.
Circ J. 2020; 84(9): 1568-74. Epub 20200717.
https://doi.org/10.1253/circj.CJ-20-0133. PMID: 32684539

Report of the use of patient-derived xenograft models in the development of anticancer drugs in Japan.
Tsumura R, Koga Y, Hamada A, Kuwata T, Sasaki H, Doi T, Aikawa K, Ohashi A, Katano I, Ikarashi Y, Ito M, Ochiai A.
Cancer Sci. 2020; 111(9): 3386-94. Epub 20200728.
https://doi.org/10.1111/cas.14564. PMID: 32639672

A Potential Mechanism of Tumor Progression during Systemic Infections Via the Hepatocyte Growth Factor (HGF)/c-Met Signaling Pathway.
Tsujimoto H, Horiguchi H, Matsumoto Y, Takahata R, Shinomiya N, Yamori T, Miyazaki H, Ono S, Saitoh D, Kishi Y, Ueno H.
J Clin Med. 2020; 9(7). Epub 20200701.
https://doi.org/10.3390/jcm9072074. PMID: 32630328

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting.
Iwasa E, Fujiyoshi Y, Kubota Y, Kimura R, Chandler RE, Taavola H, Norén GN, Wakao R.
Drug Saf. 2020; 43(11): 1121-31.
https://doi.org/10.1007/s40264-020-00968-7. PMID: 32617874

First approval of generic dry powder inhaler drug products in Japan.
Kuribayashi R, Myoenzono A.
Drug Deliv Transl Res. 2020; 10(5): 1517-9.
https://doi.org/10.1007/s13346-020-00817-1. PMID: 32613551

Strategic Outlook toward 2030: Japan's research for allergy and immunology - Secondary publication.
Adachi T, Kainuma K, Asano K, Amagai M, Arai H, Ishii KJ, Ito K, Uchio E, Ebisawa M, Okano M, Kabashima K, Kondo K, Konno S, Saeki H, Sonobe M, Nagao M, Hizawa N, Fukushima A, Fujieda S, Matsumoto K, Morita H, Yamamoto K, Yoshimoto A, Tamari M.
Allergol Int. 2020; 69(4): 561-70. Epub 20200627.
https://doi.org/10.1016/j.alit.2020.04.006. PMID: 32600925

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG.
Bmj. 2020; 369: m115. Epub 20200617.
https://doi.org/10.1136/bmj.m115. PMID: 32554564

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG.
Trials. 2020; 21(1): 528. Epub 20200617.
https://doi.org/10.1186/s13063-020-04334-x. PMID: 32546273

Achieving Regulatory Alignment for Anti-Infective Clinical Trials.
Nambiar S, Cavaleri M, Sato J.
ACS Infect Dis. 2020; 6(6): 1308-10.
https://doi.org/10.1021/acsinfecdis.0c00270. PMID: 32529834

Characteristics on Drug Safety Measures in Japan Stratified by System Organ Classes and Therapeutic Categories in Relation to the Approval Date.
Hiramatsu A, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2020; 54(6): 1534-40. Epub 20200610.
https://doi.org/10.1007/s43441-020-00180-w. PMID: 32524501

Pharmaceuticals and Medical Device Agency approval summary: Amenamevir for the treatment of herpes zoster.
Shoji N, Tanese K, Sasaki A, Horiuchi T, Utsuno Y, Fukuda K, Hoshino Y, Noda S, Minami H, Asakura W.
J Dermatol. 2020; 47(7): 683-8. Epub 20200518.
https://doi.org/10.1111/1346-8138.15393. PMID: 32424854

Oncological outcomes of a multicenter cohort treated with axitinib for metastatic renal cell carcinoma.
Osawa T, Kojima T, Hara T, Sugimoto M, Eto M, Takeuchi A, Minami K, Nakai Y, Ueda K, Ozawa M, Uemura M, Miyauchi Y, Ohba K, Suzuki T, Anai S, Shindo T, Kusakabe N, Tamura K, Komiyama M, Goto T, Yokomizo A, Kohei N, Kashiwagi A, Murakami M, Sazuka T, Yasumoto H, Iwamoto H, Mitsuzuka K, Morooka D, Shimazui T, Yamamoto Y, Ikeshiro S, Nakagomi H, Morita K, Tomida R, Mochizuki T, Inoue T, Kitamura H, Yamada S, Ito YM, Murai S, Nishiyama H, Shinohara N.
Cancer Sci. 2020; 111(7): 2460-71. Epub 20200612.
https://doi.org/10.1111/cas.14449. PMID: 32402135

'All In': a pragmatic framework for COVID-19 testing and action on a global scale.
Pettit SD, Jerome KR, Rouquié D, Mari B, Barbry P, Kanda Y, Matsumoto M, Hester S, Wehmas L, Botten JW, Bruce EA.
EMBO Mol Med. 2020; 12(6): e12634. Epub 20200527.
https://doi.org/10.15252/emmm.202012634. PMID: 32375201

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By Doing for Children.
Takahashi S, Ibrahim N, Yasukochi S, Ringel R, Ing F, Tomita H, Sugiyama H, Yamagishi M, Forbes TJ, Kim SH, Ho M, Gillette N, Nakamura Y, Mineta K, Fearnot N, Dineen D, Vang E, Haskin R, Becker LAM, Sekiguchi K, Sakamoto K, Ruiz CE.
Circ J. 2020; 84(5): 786-91. Epub 20200401.
https://doi.org/10.1253/circj.CJ-19-1092. PMID: 32238666

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
Kang HN, Thorpe R, Knezevic I.
Biologicals. 2020; 65: 1-9. Epub 20200327.
https://doi.org/10.1016/j.biologicals.2020.02.005. PMID: 32224101

Toward global standardization of conducting fair investigations of allegations of research misconduct.
Nouchi R, Aihara H, Arie F, Asashima M, Daida H, Fudano J, Fujiwara Y, Fushiki S, Geller RJ, Hatano K, Homma T, Kimura M, Kuroki T, Miki K, Morita I, Nitta K, Shinohara A, Siomi MC, Yoshida M, Ichikawa I.
Account Res. 2020; 27(6): 327-46. Epub 20200512.
https://doi.org/10.1080/08989621.2020.1747019. PMID: 32223327

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.
Konishi A, Ho M, Mitsutake Y, Ouchi T, Nakamura M, Shirato H.
Intern Med. 2021; 60(2): 161-6. Epub 20200319.
https://doi.org/10.2169/internalmedicine.4286-19. PMID: 32188811

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.
Handa N, Mochizuki S, Fujiwara Y, Shimokawa M, Wakao R, Arai H.
J Artif Organs. 2020; 23(3): 203-6. Epub 20200228.
https://doi.org/10.1007/s10047-020-01161-4. PMID: 32112156

Validation of a new serum granulocyte-macrophage colony-stimulating factor autoantibody testing kit.
Nakata K, Sugi T, Kuroda K, Yoshizawa K, Takada T, Tazawa R, Ueda T, Aoki A, Abe M, Tatsumi K, Eda R, Kondoh S, Morimoto K, Tanaka T, Yamaguchi E, Takahashi A, Oda M, Ishii H, Izumi S, Sugiyama H, Nakagawa A, Tomii K, Suzuki M, Konno S, Ohkouchi S, Hirano T, Handa T, Hirai T, Inoue Y, Arai T, Asakawa K, Sakagami T, Tanaka T, Mikami A, Kitamura N.
ERJ Open Res. 2020; 6(1). Epub 20200127.
https://doi.org/10.1183/23120541.00259-2019. PMID: 32010720

Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents.
Tohkin M, Saito Y, Yagi S, Asano K, Maekawa K, Osabe M, Iida S, Miyata N.
Drug Metab Pharmacokinet. 2020; 35(2): 187-90. Epub 20200118.
https://doi.org/10.1016/j.dmpk.2020.01.003. PMID: 32007355

WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T, Andalucia LR, Blades C, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M.
Biologicals. 2020; 65: 50-9. Epub 20200117.
https://doi.org/10.1016/j.biologicals.2019.12.008. PMID: 31959504

Big Data in the Assessment of Pediatric Medication Safety.
McMahon AW, Cooper WO, Brown JS, Carleton B, Doshi-Velez F, Kohane I, Goldman JL, Hoffman MA, Kamaleswaran R, Sakiyama M, Sekine S, Sturkenboom M, Turner MA, Califf RM.
Pediatrics. 2020; 145(2). Epub 20200114.
https://doi.org/10.1542/peds.2019-0562. PMID: 31937606

2019

Recent progress to shorten premarket evaluation and improve patient access to medical devices by the Pharmaceuticals and Medical Devices Agency of Japan.
Handa N, Takae S, Ishii K.
BMJ Surg Interv Health Technol. 2019; 1(1): e000014. Epub 20190814.
https://doi.org/10.1136/bmjsit-2019-000014. PMID: 35047777

Adverse Drug Reaction Relief System in Japan: From Clinical Perspective.
Watanabe M, Nishikawa H, Miyasaka N, Sato R, Sato D, Hayashi Y, Kondo T.
Ther Innov Regul Sci. 2020; 54(4): 731-7. Epub 20191205.
https://doi.org/10.1007/s43441-019-00003-7. PMID: 32557292

Development of a new Japanese guideline on drug interaction for drug development and appropriate provision of information.
Ishiguro A, Sato R, Nagai N.
Drug Metab Pharmacokinet. 2020; 35(1): 12-7. Epub 20191220.
https://doi.org/10.1016/j.dmpk.2019.11.009. PMID: 31902469

Comparative Study of Pharmacopoeias in Japan, Europe, and the United States: Toward the Further Convergence of International Pharmacopoeial Standards.
Kameyama Y, Matsuhama M, Mizumaru C, Saito R, Ando T, Miyazaki S.
Chem Pharm Bull (Tokyo). 2019; 67(12): 1301-13.
https://doi.org/10.1248/cpb.c19-00621. PMID: 31787657

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
Davis JM, Baer GR, McCune S, Klein A, Sato J, Fabbri L, Mangili A, Short MA, Tansey S, Mangum B, Hokuto I, Nakamura H, Salaets T, Allegaert K, Yao L, Blum M, Toerner J, Turner M, Portman R.
J Pediatr. 2020; 219: 243-9.e1. Epub 20191108.
https://doi.org/10.1016/j.jpeds.2019.09.060. PMID: 31708158

Design and Synthesis of Novel Breast Cancer Therapeutic Drug Candidates Based upon the Hydrophobic Feedback Approach of Antiestrogens.
Ohta K, Kaise A, Taguchi F, Aoto S, Ogawa T, Endo Y.
Molecules. 2019; 24(21). Epub 20191101.
https://doi.org/10.3390/molecules24213966. PMID: 31683895

Possible Contribution of Drug Approval Summaries Published by Drug Regulatory Authorities on Scientific Discussion and Drug Development.
Tanese K, Yamori T.
Clin Pharmacol Drug Dev. 2020; 9(1): 6-10. Epub 20191014.
https://doi.org/10.1002/cpdd.744. PMID: 31608600

Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases.
Yoon C, Nam KC, Lee YK, Kang Y, Choi SJ, Shin HM, Jang H, Kim JK, Kwon BS, Ishikawa H, Woo E.
J Korean Med Sci. 2019; 34(39): e255. Epub 20191014.
https://doi.org/10.3346/jkms.2019.34.e255. PMID: 31602825

Function of Prion Protein and the Family Member, Shadoo.
Onodera T, Nishimura T, Sugiura K, Sakudo A.
Curr Issues Mol Biol. 2020; 36: 67-88. Epub 20190927.
https://doi.org/10.21775/cimb.036.067. PMID: 31559969

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports.
Wakao R, Taavola H, Sandberg L, Iwasa E, Soejima S, Chandler R, Norén GN.
Drug Saf. 2019; 42(12): 1487-98.
https://doi.org/10.1007/s40264-019-00861-y. PMID: 31559542

Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting.
Konishi A, Mitsutake Y, Ho M, Handa N, Koike K, Mochizuki S, Ishii K.
J Cardiol. 2020; 75(3): 255-60. Epub 20190917.
https://doi.org/10.1016/j.jjcc.2019.07.016. PMID: 31537439

Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan.
Sakurai A, Ogawa T, Matsumoto J, Kihira T, Fukushima S, Miyata I, Shimizu H, Itamura S, Ouchi K, Hamada A, Tani K, Okabe N, Yamaguchi T.
Vaccine. 2019; 37(43): 6573-9. Epub 20190907.
https://doi.org/10.1016/j.vaccine.2019.08.031. PMID: 31506194

Establishment of the MID-NET medical information database network as a reliable and valuable database for drug safety assessments in Japan.
Yamaguchi M, Inomata S, Harada S, Matsuzaki Y, Kawaguchi M, Ujibe M, Kishiba M, Fujimura Y, Kimura M, Murata K, Nakashima N, Nakayama M, Ohe K, Orii T, Sueoka E, Suzuki T, Yokoi H, Takahashi F, Uyama Y.
Pharmacoepidemiol Drug Saf. 2019; 28(10): 1395-404. Epub 20190829.
https://doi.org/10.1002/pds.4879. PMID: 31464008

The Development of an Electronic Phenotyping Algorithm for Identifying Rhabdomyolysis Patients in the MID-NET Database.
Izukura R, Kandabashi T, Wakata Y, Nojiri C, Nohara Y, Yamashita T, Takada A, Park J, Uyama Y, Nakashima N.
Stud Health Technol Inform. 2019; 264: 1498-9.
https://doi.org/10.3233/shti190503. PMID: 31438200

ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. 2019; 30(9): 1772. Epub 20190816.
https://doi.org/10.1681/asn.2019060556. PMID: 31420407

Evolving Vision of Regulatory Science in the Global Medical Community.
Kondo T, Hayashi Y, Sato J, Sekine S, Hoshino T, Sato D.
Clin Pharmacol Ther. 2020; 107(1): 136-9. Epub 20190913.
https://doi.org/10.1002/cpt.1604. PMID: 31376148

Cardiovascular risks associated with dipeptidyl peptidase-4 inhibitors monotherapy compared with other antidiabetes drugs in the Japanese population: A nationwide cohort study.
Komamine M, Kajiyama K, Ishiguro C, Uyama Y.
Pharmacoepidemiol Drug Saf. 2019; 28(9): 1166-74. Epub 20190723.
https://doi.org/10.1002/pds.4847. PMID: 31338935

Identification of gastrointestinal perforation based on ICD-10 code in a Japanese administrative medical information database and associated drug exposure risk factors.
Tanigawa M, Kataoka Y, Kishino T, Kohama M, Uyama Y, Suzuki Y, Yokoi H.
Pharmacoepidemiol Drug Saf. 2019; 28(7): 976-84. Epub 20190613.
https://doi.org/10.1002/pds.4837. PMID: 31197887

Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk.
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC.
Eur Heart J. 2019; 40(31): 2632-53.
https://doi.org/10.1093/eurheartj/ehz372. PMID: 31116395

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC.
Circulation. 2019; 140(3): 240-61. Epub 20190522.
https://doi.org/10.1161/circulationaha.119.040167. PMID: 31116032

Applications of MALDI mass spectrometry imaging for pharmacokinetic studies during drug development.
Nishidate M, Hayashi M, Aikawa H, Tanaka K, Nakada N, Miura SI, Ryu S, Higashi T, Ikarashi Y, Fujiwara Y, Hamada A.
Drug Metab Pharmacokinet. 2019; 34(4): 209-16. Epub 20190424.
https://doi.org/10.1016/j.dmpk.2019.04.006. PMID: 31101590

Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan.
Kuribayashi R, Myoenzono A, Takagi K, Hirota M.
Eur J Drug Metab Pharmacokinet. 2019; 44(6): 743-5.
https://doi.org/10.1007/s13318-019-00561-z. PMID: 31062276

Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology.
Salgado R, Solit DB, Rimm DL, Bogaerts J, Canetta R, Lively T, Lyerly K, Span PN, Bateman-House A, Makady A, Bergmann L, Nagai S, Smith C, Robson M, Savage M, Voest E, Sweeney C, Lambin P, Thomas M, Harris L, Lacombe D, Massard C.
Eur J Cancer. 2019; 114: 128-36. Epub 20190503.
https://doi.org/10.1016/j.ejca.2019.03.025. PMID: 31060925

Regulatory approval review of transcatheter mitral valve repair - Difference in the indication between the USA and Japan.
Konishi A, Ho M, Ouchi T, Mitsutake Y, Shirato H.
J Cardiol. 2019; 74(1): 13-8. Epub 20190417.
https://doi.org/10.1016/j.jjcc.2019.03.013. PMID: 31005388

The utilization and challenges of Japan's MID-NET medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies.
Yamada K, Itoh M, Fujimura Y, Kimura M, Murata K, Nakashima N, Nakayama M, Ohe K, Orii T, Sueoka E, Suzuki T, Yokoi H, Ishiguro C, Uyama Y.
Pharmacoepidemiol Drug Saf. 2019; 28(5): 601-8. Epub 20190403.
https://doi.org/10.1002/pds.4777. PMID: 30945387

Pediatric drug regulation: International perspectives.
Baum VC, Bax R, Heon D, Yang Z, Sakiyama M.
Paediatr Anaesth. 2019; 29(6): 572-82. Epub 20190414.
https://doi.org/10.1111/pan.13638. PMID: 30924233

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials.
Nonaka T, Igeta M, Matsui S.
Pharm Stat. 2019; 18(4): 459-75. Epub 20190305.
https://doi.org/10.1002/pst.1937. PMID: 30838777

Oseltamivir phosphate-Lifting the restriction on its use to treat teenagers with influenza in Japan.
Takeuchi S, Tetsuhashi M, Sato D.
Pharmacoepidemiol Drug Saf. 2019; 28(4): 434-6. Epub 20190304.
https://doi.org/10.1002/pds.4721. PMID: 30834626

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.
Sai K, Yoshida A, Hanatani T, Imatoh T, Takeuchi M, Narukawa M, Watanabe H, Uyama Y, Saito Y.
Br J Clin Pharmacol. 2019; 85(6): 1270-82. Epub 20190328.
https://doi.org/10.1111/bcp.13893. PMID: 30735569

Promotion of Japan's participation in global clinical trials.
Kondo H, Shimada Y, Ozawa T.
Drug Discov Today. 2019; 24(4): 939-42. Epub 20190130.
https://doi.org/10.1016/j.drudis.2019.01.016. PMID: 30710642

A practice of expert review by read-across using QSAR Toolbox.
Fukuchi J, Kitazawa A, Hirabayashi K, Honma M.
Mutagenesis. 2019; 34(1): 49-54.
https://doi.org/10.1093/mutage/gey046. PMID: 30690463

Optimal follow-up intervals for different stages of chronic kidney disease: a prospective observational study.
Hirano K, Kobayashi D, Kohtani N, Uemura Y, Ohashi Y, Komatsu Y, Yanagita M, Hishida A.
Clin Exp Nephrol. 2019; 23(5): 613-20. Epub 20190128.
https://doi.org/10.1007/s10157-018-01684-4. PMID: 30687877

Visit-to-visit variability in estimated glomerular filtration rate predicts hospitalization and death due to cardiovascular events.
Suzuki A, Obi Y, Hayashi T, Kotani N, Uemura Y, Imai E, Makino H, Hishida A.
Clin Exp Nephrol. 2019; 23(5): 661-8. Epub 20190128.
https://doi.org/10.1007/s10157-019-01695-9. PMID: 30687876

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan.
Takami A, Hirata K, Ishiguro C, Hanaoka H, Uyama Y.
Clin Pharmacol Ther. 2019; 105(6): 1471-6. Epub 20190210.
https://doi.org/10.1002/cpt.1342. PMID: 30588617

2018

Global Regulatory Landscape.
Matsuda Y.
AAPS PharmSciTech. 2018; 20(1): 2. Epub 20181217.
https://doi.org/10.1208/s12249-018-1230-x. PMID: 30560302

Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers.
Lyerly HK, Ren J, Canetta R, Kim GH, Nagai S, Yamaguchi T, Hatogai K, Katayama H, Da Rocha Dias S, McManus D, Soltys K, Yang Z, Olopade O, Goodman N, Reaman G, Gross T.
J Glob Oncol. 2018; 4: 1-11.
https://doi.org/10.1200/jgo.18.00092. PMID: 30521412

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.
Dimairo M, Coates E, Pallmann P, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, Koenig F, Walton MK, Biggs K, Nicholl J, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG.
BMC Med. 2018; 16(1): 210. Epub 20181116.
https://doi.org/10.1186/s12916-018-1196-2. PMID: 30442137

Antitumor profile of the PI3K inhibitor ZSTK474 in human sarcoma cell lines.
Namatame N, Tamaki N, Yoshizawa Y, Okamura M, Nishimura Y, Yamazaki K, Tanaka M, Nakamura T, Semba K, Yamori T, Yaguchi SI, Dan S.
Oncotarget. 2018; 9(80): 35141-61. Epub 20181012.
https://doi.org/10.18632/oncotarget.26216. PMID: 30416685

Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective - Reply.
Yokoi H, Ho M, Iwamoto S.
Circ J. 2018; 82(12): 3111. Epub 20181030.
https://doi.org/10.1253/circj.CJ-18-1066. PMID: 30381694

The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts.
Harrison RW, Radhakrishnan V, Allen JC, Jr., Lam PS, Allocco DJ, Brar S, Fahy M, Zhang Z, Fisher R, Ikeno F, Généreux P, Kimura T, Liu M, Lye WK, Nagai H, Suzuki Y, White R, Krucoff MW.
Am Heart J. 2018; 206: 61-71. Epub 20180907.
https://doi.org/10.1016/j.ahj.2018.08.017. PMID: 30342296

Cell-based chemical fingerprinting identifies telomeres and lamin A as modifiers of DNA damage response in cancer cells.
Fujiwara C, Muramatsu Y, Nishii M, Tokunaka K, Tahara H, Ueno M, Yamori T, Sugimoto Y, Seimiya H.
Sci Rep. 2018; 8(1): 14827. Epub 20181004.
https://doi.org/10.1038/s41598-018-33139-x. PMID: 30287851

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.
Watanabe K, Murakami M, Masuyama K, Ishiguro C, Matsuda T.
Pharmacoepidemiol Drug Saf. 2018; 27(11): 1265-76. Epub 20180925.
https://doi.org/10.1002/pds.4662. PMID: 30252199

Master protocol trials in oncology: Review and new trial designs.
Hirakawa A, Asano J, Sato H, Teramukai S.
Contemp Clin Trials Commun. 2018; 12: 1-8. Epub 20180824.
https://doi.org/10.1016/j.conctc.2018.08.009. PMID: 30182068

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework.
Tsukamoto K, Cnop M, Mori D, Kume S, Anazawa T, Doi M, Chikazawa K, Matsumaru N.
Ther Innov Regul Sci. 2019; 53(4): 535-41. Epub 20180903.
https://doi.org/10.1177/2168479018795854. PMID: 30176740

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X.
Aaps j. 2018; 20(6): 93. Epub 20180827.
https://doi.org/10.1208/s12248-018-0252-3. PMID: 30151612

Cryo-EM structures of the human volume-regulated anion channel LRRC8.
Kasuya G, Nakane T, Yokoyama T, Jia Y, Inoue M, Watanabe K, Nakamura R, Nishizawa T, Kusakizako T, Tsutsumi A, Yanagisawa H, Dohmae N, Hattori M, Ichijo H, Yan Z, Kikkawa M, Shirouzu M, Ishitani R, Nureki O.
Nat Struct Mol Biol. 2018; 25(9): 797-804. Epub 20180820.
https://doi.org/10.1038/s41594-018-0109-6. PMID: 30127360

Determining Food Allergens by Skin Sensitization in Mice.
Tamehiro N, Adachi R, Kimura Y, Sakai S, Teshima R, Kondo K.
Curr Protoc Toxicol. 2018; 76(1): e48. Epub 20180430.
https://doi.org/10.1002/cptx.48. PMID: 30040230

Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices.
Kanda E, Kashihara N, Matsushita K, Usui T, Okada H, Iseki K, Mikami K, Tanaka T, Wada T, Watada H, Ueki K, Nangaku M.
Clin Exp Nephrol. 2018; 22(6): 1446-75.
https://doi.org/10.1007/s10157-018-1615-x. PMID: 30006871

Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese Perspective.
Yokoi H, Ho M, Iwamoto S, Suzuki Y, Ansel GM, Azuma N, Handa N, Iida O, Ikeda K, Ikeno F, Ohura N, Rosenfield K, Rundback J, Terashi H, Uchida T, Yokoi Y, Nakamura M, Jaff MR.
Circ J. 2018; 82(9): 2233-9. Epub 20180630.
https://doi.org/10.1253/circj.CJ-18-0014. PMID: 29962385

A Novel Method to Estimate Long-Term Chronological Changes From Fragmented Observations in Disease Progression.
Ishida T, Tokuda K, Hisaka A, Honma M, Kijima S, Takatoku H, Iwatsubo T, Moritoyo T, Suzuki H.
Clin Pharmacol Ther. 2019; 105(2): 436-47. Epub 20180820.
https://doi.org/10.1002/cpt.1166. PMID: 29951994

Regulatory convergence of medical devices: a case study using ISO and IEC standards.
Imagawa K, Mizukami Y, Miyazaki S.
Expert Rev Med Devices. 2018; 15(7): 497-504. Epub 20180711.
https://doi.org/10.1080/17434440.2018.1492376. PMID: 29936871

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM.
Lancet Haematol. 2018; 5(11): e563-e98. Epub 20180618.
https://doi.org/10.1016/s2352-3026(18)30051-6. PMID: 29907552

Critical roles of inflammation in atherosclerosis.
Moriya J.
J Cardiol. 2019; 73(1): 22-7. Epub 20180612.
https://doi.org/10.1016/j.jjcc.2018.05.010. PMID: 29907363

Current state of therapeutic development for rare cancers in Japan, and proposals for improvement.
Kawai A, Goto T, Shibata T, Tani K, Mizutani S, Nishikawa A, Shibata T, Matsumoto S, Nagata K, Narukawa M, Matsui S, Ando M, Toguchida J, Monden M, Heike T, Kimura S, Ueda R.
Cancer Sci. 2018; 109(5): 1731-7.
https://doi.org/10.1111/cas.13568. PMID: 29878624

Learning Curve for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System - Initial Analysis of a Japanese Nationwide Registry.
Handa N, Kumamaru H, Torikai K, Kohsaka S, Takayama M, Kobayashi J, Ogawa H, Shirato H, Ishii K, Koike K, Yokoyama Y, Miyata H, Motomura N, Sawa Y.
Circ J. 2018; 82(7): 1951-8. Epub 20180522.
https://doi.org/10.1253/circj.CJ-18-0211. PMID: 29794375

Freeze-dried equine-derived redback spider antivenom: a local irritation study by intramuscular injection in rabbits and a repeated-dose toxicity study in rats.
Yamamoto A, Harano S, Shinya N, Nagano A, Miyatsu Y, Sawabe K, Matsumura T, Ato M, Takahashi M, Taki H, Hifumi T.
J Toxicol Pathol. 2018; 31(2): 105-12. Epub 20180219.
https://doi.org/10.1293/tox.2017-0053. PMID: 29749999

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.
Kondo H, Shibatsuji M, Yasuda N.
Ther Innov Regul Sci. 2019; 53(2): 193-8. Epub 20180502.
https://doi.org/10.1177/2168479018771312. PMID: 29719977

Points-to-consider documents: Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population.
Hiratsuka M, Hirasawa N, Oshima Y, Kodama S, Miyata T, Dan T, Takatoku H, Kuribayashi H, Nakamura R, Saito Y.
Drug Metab Pharmacokinet. 2018; 33(3): 141-9. Epub 20180315.
https://doi.org/10.1016/j.dmpk.2018.01.005. PMID: 29703433

Accelerating Cell Therapy for Stroke in Japan: Regulatory Framework and Guidelines on Development of Cell-Based Products.
Houkin K, Shichinohe H, Abe K, Arato T, Dezawa M, Honmou O, Horie N, Katayama Y, Kudo K, Kuroda S, Matsuyama T, Miyai I, Nagata I, Niizuma K, Sakushima K, Sasaki M, Sato N, Sawanobori K, Suda S, Taguchi A, Tominaga T, Yamamoto H, Yamashita T, Yoshimine T.
Stroke. 2018; 49(4): e145-e52. Epub 20180316.
https://doi.org/10.1161/strokeaha.117.019216. PMID: 29581346

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.
Konishi A, Ho M, Shirai Y, Shirato H.
Circ J. 2018; 82(6): 1487-90. Epub 20180321.
https://doi.org/10.1253/circj.CJ-17-1425. PMID: 29563353

New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies.
Konishi A, Isobe S, Sato D.
J Vasc Interv Radiol. 2018; 29(5): 657-60. Epub 20180313.
https://doi.org/10.1016/j.jvir.2017.12.022. PMID: 29548874

Venom and Antivenom of the Redback Spider (Latrodectus hasseltii) in Japan. Part I. Venom Extraction, Preparation, and Laboratory Testing.
Matsumura T, Mashiko R, Sato T, Itokawa K, Maekawa Y, Ogawa K, Isawa H, Yamamoto A, Mori S, Horita A, Ginnaga A, Miyatsu Y, Takahashi M, Taki H, Hifumi T, Sawabe K, Ato M.
Jpn J Infect Dis. 2018; 71(2): 116-21. Epub 20180228.
https://doi.org/10.7883/yoken.JJID.2017.291. PMID: 29491237

An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance.
Misu T, Kortepeter CM, Muñoz MA, Wu E, Dal Pan GJ.
Drugs Real World Outcomes. 2018; 5(2): 91-9.
https://doi.org/10.1007/s40801-018-0131-3. PMID: 29476420

Physiologically Based Pharmacokinetic Modeling of Bosentan Identifies the Saturable Hepatic Uptake As a Major Contributor to Its Nonlinear Pharmacokinetics.
Sato M, Toshimoto K, Tomaru A, Yoshikado T, Tanaka Y, Hisaka A, Lee W, Sugiyama Y.
Drug Metab Dispos. 2018; 46(5): 740-8. Epub 20180223.
https://doi.org/10.1124/dmd.117.078972. PMID: 29475833

TUFT1 interacts with RABGAP1 and regulates mTORC1 signaling.
Kawasaki N, Isogaya K, Dan S, Yamori T, Takano H, Yao R, Morishita Y, Taguchi L, Morikawa M, Heldin CH, Noda T, Ehata S, Miyazono K, Koinuma D.
Cell Discov. 2018; 4: 1. Epub 20180109.
https://doi.org/10.1038/s41421-017-0001-2. PMID: 29423269

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.
Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein RA, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL.
J Vasc Surg. 2018; 67(2): 637-44.e30.
https://doi.org/10.1016/j.jvs.2017.07.141. PMID: 29389426

Registry Assessment of Peripheral Interventional Devices (RAPID) - Registry Assessment of Peripheral Interventional Devices Core Data Elements.
Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein R, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL.
Circ J. 2018; 82(2): 316-22. Epub 20180123.
https://doi.org/10.1253/circj.CJ-17-1156. PMID: 29367497

Impact of demographic factors on the antidepressant effect: A patient-level data analysis from depression trials submitted to the Pharmaceuticals and Medical Devices Agency in Japan.
Nakabayashi T, Hara A, Minami H.
J Psychiatr Res. 2018; 98: 116-23. Epub 20180103.
https://doi.org/10.1016/j.jpsychires.2017.12.019. PMID: 29334636

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs.
Hoshino T, Muto N, Tsukada S, Nakamura T, Maegawa H.
Medicines (Basel). 2018; 5(1). Epub 20180106.
https://doi.org/10.3390/medicines5010003. PMID: 29316611

Proposal for the development of biologics in pediatric rheumatology.
Mori M, Nakagawa M, Tsuchida N, Kawada K, Sato J, Sakiyama M, Hirano S, Sato K, Nakamura H.
Pediatr Int. 2018; 60(2): 108-14.
https://doi.org/10.1111/ped.13495. PMID: 29288517

2017

Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council.
Hattori Y, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2017; 51(4): 426-30. Epub 20170307.
https://doi.org/10.1177/2168479017696271. PMID: 30227059

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.
Kondo H, Saint-Raymond A, Yasuda N.
Ther Innov Regul Sci. 2018; 52(2): 214-9. Epub 20170721.
https://doi.org/10.1177/2168479017720248. PMID: 29714521

Targeting the Golgi apparatus to overcome acquired resistance of non-small cell lung cancer cells to EGFR tyrosine kinase inhibitors.
Ohashi Y, Okamura M, Katayama R, Fang S, Tsutsui S, Akatsuka A, Shan M, Choi HW, Fujita N, Yoshimatsu K, Shiina I, Yamori T, Dan S.
Oncotarget. 2018; 9(2): 1641-55. Epub 20171206.
https://doi.org/10.18632/oncotarget.22895. PMID: 29416720

WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.
Wadhwa M, Kang HN, Hamel H, Jivapaisarnpong T.
Biologicals. 2018; 52: 83-91. Epub 20171227.
https://doi.org/10.1016/j.biologicals.2017.12.002. PMID: 29289489

Mucosal-Associated Invariant T Cells in Regenerative Medicine.
Wakao H, Sugimoto C, Kimura S, Wakao R.
Front Immunol. 2017; 8: 1711. Epub 20171201.
https://doi.org/10.3389/fimmu.2017.01711. PMID: 29250077

Combined therapy with gas gangrene antitoxin and recombinant human soluble thrombomodulin for Clostridium perfringens sepsis in a rat model.
Hifumi T, Nakano D, Chiba J, Takahashi M, Yamamoto A, Fujisawa Y, Kawakita K, Kuroda Y, Nishiyama A.
Toxicon. 2018; 141: 112-7. Epub 20171212.
https://doi.org/10.1016/j.toxicon.2017.12.043. PMID: 29246581

Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan.
Asano K, Uyama Y, Tohkin M.
Clin Transl Sci. 2018; 11(2): 182-8. Epub 20171115.
https://doi.org/10.1111/cts.12520. PMID: 29139198

Angiogenesis, Cancer, and Vascular Aging.
Moriya J, Minamino T.
Front Cardiovasc Med. 2017; 4: 65. Epub 20171024.
https://doi.org/10.3389/fcvm.2017.00065. PMID: 29114540

Current Japanese Regulatory Systems for Generics and Biosimilars.
Kuribayashi R, Sawanobori K.
J Pharm Sci. 2018; 107(3): 785-7. Epub 20171104.
https://doi.org/10.1016/j.xphs.2017.10.040. PMID: 29113922

Molecular phylogenetic analysis of new Entoloma rhodopolium-related species in Japan and its identification method using PCR-RFLP.
Kondo K, Nakamura K, Ishigaki T, Sakata K, Obitsu S, Noguchi A, Fukuda N, Nagasawa E, Teshima R, Nishimaki-Mogami T.
Sci Rep. 2017; 7(1): 14942. Epub 20171102.
https://doi.org/10.1038/s41598-017-14466-x. PMID: 29097736

Venom and Antivenom of the Redback Spider (Latrodectus hasseltii) in Japan. Part II. Experimental Production of Equine Antivenom against the Redback Spider.
Mori S, Horita A, Ginnaga A, Miyatsu Y, Sawabe K, Matsumura T, Ato M, Yamamoto A, Shibayama K, Arai S, Yamagishi T, Takahashi M, Taki H, Hifumi T.
Jpn J Infect Dis. 2017; 70(6): 635-41. Epub 20171031.
https://doi.org/10.7883/yoken.JJID.2017.125. PMID: 29093316

Desulfation of Heparan Sulfate by Sulf1 and Sulf2 Is Required for Corticospinal Tract Formation.
Okada T, Keino-Masu K, Nagamine S, Kametani F, Ohto T, Hasegawa M, van Kuppevelt TH, Kunita S, Takahashi S, Masu M.
Sci Rep. 2017; 7(1): 13847. Epub 20171023.
https://doi.org/10.1038/s41598-017-14185-3. PMID: 29062064

Dioxin concentrations in dietary supplements containing animal oil on the Japanese market between 2007 and 2014.
Tsutsumi T, Takatsuki S, Teshima R, Matsuda R, Watanabe T, Akiyama H.
Chemosphere. 2018; 191: 514-9. Epub 20171010.
https://doi.org/10.1016/j.chemosphere.2017.10.046. PMID: 29059558

Japanese registry for Mechanically Assisted Circulatory Support: First report.
Nakatani T, Sase K, Oshiyama H, Akiyama M, Horie M, Nawata K, Nishinaka T, Tanoue Y, Toda K, Tozawa M, Yamazaki S, Yanase M, Ohtsu H, Ishida M, Hiramatsu A, Ishii K, Kitamura S.
J Heart Lung Transplant. 2017; 36(10): 1087-96. Epub 20170812.
https://doi.org/10.1016/j.healun.2017.08.002. PMID: 28942783

Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan.
Somekawa L, Maegawa H, Tsukada S, Nakamura T.
J Intercult Ethnopharmacol. 2017; 6(3): 333-8. Epub 20170716.
https://doi.org/10.5455/jice.20170713091550. PMID: 28894633

Investigating toxicity specific to adjuvanted vaccines.
Matsumoto M, Komatsu SI, Ikeda T, Shimomura K, Watanabe K, Hirabayashi K, Sawada JI, Maki K, Shinoda K, Fueki O, Onodera H.
Regul Toxicol Pharmacol. 2017; 91: 29-38. Epub 20170906.
https://doi.org/10.1016/j.yrtph.2017.09.003. PMID: 28888957

Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.
Murakami M, Suzuki Y, Tominaga T.
Circ J. 2018; 82(3): 636-43. Epub 20170907.
https://doi.org/10.1253/circj.CJ-17-0533. PMID: 28883226

Societal challenges of precision medicine: Bringing order to chaos.
Salgado R, Moore H, Martens JWM, Lively T, Malik S, McDermott U, Michiels S, Moscow JA, Tejpar S, McKee T, Lacombe D.
Eur J Cancer. 2017; 84: 325-34. Epub 20170904.
https://doi.org/10.1016/j.ejca.2017.07.028. PMID: 28865260

Low-Concentration Tributyltin Decreases GluR2 Expression via Nuclear Respiratory Factor-1 Inhibition.
Ishida K, Aoki K, Takishita T, Miyara M, Sakamoto S, Sanoh S, Kimura T, Kanda Y, Ohta S, Kotake Y.
Int J Mol Sci. 2017; 18(8). Epub 20170811.
https://doi.org/10.3390/ijms18081754. PMID: 28800112

Prevention of sudden cardiac death in the young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium.
Idriss SF, Berger S, Harmon KG, Kindman A, Kleiman R, Lopez-Anderson M, Molossi S, Saarel TE, Strnadova C, Todaro T, Shinagawa K, Morrow V, Krucoff M, Vetter V, Wright TJ.
Am Heart J. 2017; 190: 123-31. Epub 20170518.
https://doi.org/10.1016/j.ahj.2017.05.003. PMID: 28760206

Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.
Ishiguro C, Misu T, Iwasa E, Izawa T.
Pharmacoepidemiol Drug Saf. 2017; 26(11): 1314-20. Epub 20170719.
https://doi.org/10.1002/pds.4252. PMID: 28722235

Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia.
Miyazaki K, Sato Y, Hanaoka H, Uyama Y.
Clin Transl Sci. 2017; 10(6): 503-8. Epub 20170704.
https://doi.org/10.1111/cts.12485. PMID: 28675655

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.
Nasr MM, Krumme M, Matsuda Y, Trout BL, Badman C, Mascia S, Cooney CL, Jensen KD, Florence A, Johnston C, Konstantinov K, Lee SL.
J Pharm Sci. 2017; 106(11): 3199-206. Epub 20170626.
https://doi.org/10.1016/j.xphs.2017.06.015. PMID: 28655487

Targeting glioma stem cells in vivo by a G-quadruplex-stabilizing synthetic macrocyclic hexaoxazole.
Nakamura T, Okabe S, Yoshida H, Iida K, Ma Y, Sasaki S, Yamori T, Shin-Ya K, Nakano I, Nagasawa K, Seimiya H.
Sci Rep. 2017; 7(1): 3605. Epub 20170615.
https://doi.org/10.1038/s41598-017-03785-8. PMID: 28620243

Comparative study of the number of report and time-to-onset of the reported adverse event between the biosimilars and the originator of filgrastim.
Kobayashi T, Kamada I, Komura J, Toyoshima S, Ishii-Watabe A.
Pharmacoepidemiol Drug Saf. 2017; 26(8): 917-24. Epub 20170614.
https://doi.org/10.1002/pds.4218. PMID: 28612945

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.
Kuribayashi R, Appleton S.
Drugs R D. 2017; 17(3): 371-9.
https://doi.org/10.1007/s40268-017-0186-8. PMID: 28577294

Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective.
Sato M, Ochiai Y, Kijima S, Nagai N, Ando Y, Shikano M, Nomura Y.
CPT Pharmacometrics Syst Pharmacol. 2017; 6(7): 413-5. Epub 20170601.
https://doi.org/10.1002/psp4.12203. PMID: 28568566

Improving public health by improving clinical trial guidelines and their application.
Landray MJ, Bax JJ, Alliot L, Buyse M, Cohen A, Collins R, Hindricks G, James SK, Lane S, Maggioni AP, Meeker-O'Connell A, Olsson G, Pocock SJ, Rawlins M, Sellors J, Shinagawa K, Sipido KR, Smeeth L, Stephens R, Stewart MW, Stough WG, Sweeney F, Van de Werf F, Woods K, Casadei B.
Eur Heart J. 2017; 38(21): 1632-7.
https://doi.org/10.1093/eurheartj/ehx086. PMID: 28329235

Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: Application to breast cancer data.
Asano J, Hirakawa A.
J Biopharm Stat. 2017; 27(6): 918-32. Epub 20170321.
https://doi.org/10.1080/10543406.2017.1293082. PMID: 28324665

Non-neoplastic lesions found only in the two-year bioassays but not in shorter toxicity studies of rats.
Nonaka M, Amakasu K, Saegusa Y, Naota M, Nishimura T, Ogawa K, Nishikawa A.
Regul Toxicol Pharmacol. 2017; 86: 199-204. Epub 20170310.
https://doi.org/10.1016/j.yrtph.2017.03.008. PMID: 28288808

Clinical Study of New Tetravalent (Type A, B, E, and F) Botulinum Toxoid Vaccine Derived from M Toxin in Japan.
Torii Y, Sugimoto N, Kohda T, Kozaki S, Morokuma K, Horikawa Y, Ginnaga A, Yamamoto A, Takahashi M.
Jpn J Infect Dis. 2017; 70(4): 423-9. Epub 20170228.
https://doi.org/10.7883/yoken.JJID.2016.360. PMID: 28250257

Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.
Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K.
Clin Pharmacokinet. 2017; 56(3): 225-33.
https://doi.org/10.1007/s40262-016-0438-8. PMID: 27461251

Pediatric Crohn Disease Clinical Outcome Assessments and Biomarkers: Current State and Path Forward for Global Collaboration.
Sun H, Vesely R, Lee KJ, Klein A, Ikima M, Mulberg AE.
J Pediatr Gastroenterol Nutr. 2017; 64(3): 368-72.
https://doi.org/10.1097/mpg.0000000000001284. PMID: 27253661

2016

Response to Nature's editorial regarding the Japanese legal system for regenerative medicines.
Sato D, Arakawa Y, Isobe S.
Regen Ther. 2016; 4: 103-4. Epub 20160602.
https://doi.org/10.1016/j.reth.2016.04.003. PMID: 31245493

Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine.
Tobita M, Konomi K, Torashima Y, Kimura K, Taoka M, Kaminota M.
Regen Ther. 2016; 4: 78-81. Epub 20160531.
https://doi.org/10.1016/j.reth.2016.04.001. PMID: 31245489

The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States.
Kondo H, Hata T, Ito K, Koike H, Kono N.
Ther Innov Regul Sci. 2017; 51(1): 51-4. Epub 20160927.
https://doi.org/10.1177/2168479016662682. PMID: 30235998

Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression.
Tanemura N, Uyama Y, Nagashima K, Suzuki T, Asahina Y, Kobayashi Y, Iyo M, Yokote K, Hanaoka H.
Ther Innov Regul Sci. 2016; 50(6): 743-50. Epub 20160710.
https://doi.org/10.1177/2168479016648731. PMID: 30231732

Risk of Acute Asthma Attacks Associated With Nonsteroidal Anti-inflammatory Drugs: A Self-Controlled Case Series.
Takeuchi Y, Ando T, Ishiguro C, Uyama Y.
Ther Innov Regul Sci. 2017; 51(3): 332-41. Epub 20161229.
https://doi.org/10.1177/2168479016679865. PMID: 30231709

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products.
Kondo H, Sugita T, Ida N, Fukushima H, Yasuda N.
Ther Innov Regul Sci. 2017; 51(3): 355-9. Epub 20161218.
https://doi.org/10.1177/2168479016680259. PMID: 30231707

Transduction Properties of Adenovirus Serotype 35 Vectors After Intravenous Administration Into Nonhuman Primates.
Sakurai F, Nakamura SI, Akitomo K, Shibata H, Terao K, Kawabata K, Hayakawa T, Mizuguchi H.
Mol Ther. 2008; 16(4): 726-33. Epub 20161208.
https://doi.org/10.1038/mt.2008.19. PMID: 28178464

A novel thiophene-3-carboxamide analog of annonaceous acetogenin exhibits antitumor activity via inhibition of mitochondrial complex I.
Akatsuka A, Kojima N, Okamura M, Dan S, Yamori T.
Pharmacol Res Perspect. 2016; 4(4): e00246. Epub 20160712.
https://doi.org/10.1002/prp2.246. PMID: 28116099

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.
Harrison RW, Radhakrishnan V, Lam PS, Allocco DJ, Brar S, Fahy M, Fisher R, Ikeno F, Généreux P, Kimura T, Liu M, Lye WK, Mintz GS, Nagai H, Suzuki Y, White R, Allen JC, Jr., Krucoff MW.
Am Heart J. 2016; 182: 103-10. Epub 20160803.
https://doi.org/10.1016/j.ahj.2016.07.011. PMID: 27914489

The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.
Tominaga T, Miyazaki S, Oniyama Y, Weber AD, Kondo T.
Clin Pharmacol Ther. 2017; 102(2): 277-82. Epub 20161207.
https://doi.org/10.1002/cpt.537. PMID: 27737512

The health care and life sciences community profile for dataset descriptions.
Dumontier M, Gray AJG, Marshall MS, Alexiev V, Ansell P, Bader G, Baran J, Bolleman JT, Callahan A, Cruz-Toledo J, Gaudet P, Gombocz EA, Gonzalez-Beltran AN, Groth P, Haendel M, Ito M, Jupp S, Juty N, Katayama T, Kobayashi N, Krishnaswami K, Laibe C, Le Novère N, Lin S, Malone J, Miller M, Mungall CJ, Rietveld L, Wimalaratne SM, Yamaguchi A.
PeerJ. 2016; 4: e2331. Epub 20160816.
https://doi.org/10.7717/peerj.2331. PMID: 27602295

Effect of design specifications in dose-finding trials for combination therapies in oncology.
Hirakawa A, Sato H, Gosho M.
Pharm Stat. 2016; 15(6): 531-40. Epub 20160819.
https://doi.org/10.1002/pst.1770. PMID: 27539365

The dynamics of mucosal-associated invariant T cells in multiple sclerosis.
Sugimoto C, Hirotani M, Yoshikiyo K, Koshimizu U, Wakao R, Horinouchi T, Mazaki Y, Higashi T, Fukazawa T, Fujita H, Sasaki H, Wakao H.
Springerplus. 2016; 5(1): 1259. Epub 20160805.
https://doi.org/10.1186/s40064-016-2923-9. PMID: 27536542

Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.
Matsuhama M, Takishita T, Kuribayashi R, Takagi K, Wakao R, Mikami K.
J Pharm Pharm Sci. 2016; 19(2): 290-301.
https://doi.org/10.18433/jpps.v19i2.27066. PMID: 27518176

Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S.
Biologicals. 2016; 44(5): 467-79. Epub 20160722.
https://doi.org/10.1016/j.biologicals.2016.06.002. PMID: 27461129

Late Sac Behavior after Endovascular Aneurysm Repair for Abdominal Aortic Aneurysm.
Okada M, Handa N, Onohara T, Okamoto M, Yamamoto T, Shimoe Y, Yamashita M, Takahashi T, Kishimoto J, Mizuno A, Kei J, Nakai M, Sakaki M, Suhara H, Kasashima F, Endo M, Nishina T, Furuyama T, Kawasaki M, Iwata K, Marumoto A, Urata Y, Sato K, Ryugo M.
Ann Vasc Dis. 2016; 9(2): 102-7. Epub 20160602.
https://doi.org/10.3400/avd.oa.15-00125. PMID: 27375803

Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.
Kuribayashi R, Takishita T, Mikami K.
J Pharm Sci. 2016; 105(8): 2270-7. Epub 20160630.
https://doi.org/10.1016/j.xphs.2016.05.026. PMID: 27372551

Synthesis and biological evaluation of novel FK228 analogues as potential isoform selective HDAC inhibitors.
Narita K, Matsuhara K, Itoh J, Akiyama Y, Dan S, Yamori T, Ito A, Yoshida M, Katoh T.
Eur J Med Chem. 2016; 121: 592-609. Epub 20160518.
https://doi.org/10.1016/j.ejmech.2016.05.031. PMID: 27318982

M-COPA, a novel Golgi system disruptor, suppresses apoptosis induced by Shiga toxin.
Hattori T, Watanabe-Takahashi M, Shiina I, Ohashi Y, Dan S, Nishikawa K, Yamori T, Naito M.
Genes Cells. 2016; 21(8): 901-6. Epub 20160615.
https://doi.org/10.1111/gtc.12386. PMID: 27302278

Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps.
Mentz RJ, Roessig L, Greenberg BH, Sato N, Shinagawa K, Yeo D, Kwok BW, Reyes EB, Krum H, Pieske B, Greene SJ, Ambrosy AP, Kelly JP, Zannad F, Pitt B, Lam CS.
JACC Heart Fail. 2016; 4(6): 419-27.
https://doi.org/10.1016/j.jchf.2016.01.013. PMID: 27256745

The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan.
Ishiguro C, Takeuchi Y, Uyama Y, Tawaragi T.
Pharmacoepidemiol Drug Saf. 2016; 25(7): 854-9. Epub 20160525.
https://doi.org/10.1002/pds.4032. PMID: 27222073

An adaptive dose-finding method using a change-point model for molecularly targeted agents in phase I trials.
Sato H, Hirakawa A, Hamada C.
Stat Med. 2016; 35(23): 4093-109. Epub 20160511.
https://doi.org/10.1002/sim.6981. PMID: 27221807

First Approval of Regenerative Medical Products under the PMD Act in Japan.
Konishi A, Sakushima K, Isobe S, Sato D.
Cell Stem Cell. 2016; 18(4): 434-5.
https://doi.org/10.1016/j.stem.2016.03.011. PMID: 27058934

Fetal Environment and Glycosylation Status in Neonatal Cord Blood: A Comprehensive Mass Spectrometry-based Glycosylation Analysis.
Sato R, Tsuchiya KJ, Matsuzaki H, Takei N, Itoh H, Kanayama N, Suda T, Watanabe H, Ohashi T, Tanaka M, Nishimura SI, Maekawa M.
Medicine (Baltimore). 2016; 95(14): e3219.
https://doi.org/10.1097/md.0000000000003219. PMID: 27057853

Glycaemia and autistic traits in very low birth weight infants in adulthood.
Sato R, Shirai K, Maekawa M, Genma R, Ohki S, Morita H, Suda T, Watanabe H.
Diabetes Metab. 2016; 42(4): 285-6. Epub 20160329.
https://doi.org/10.1016/j.diabet.2016.02.005. PMID: 27037012

Adverse events associated with incretin-based drugs in Japanese spontaneous reports: a mixed effects logistic regression model.
Narushima D, Kawasaki Y, Takamatsu S, Yamada H.
PeerJ. 2016; 4: e1753. Epub 20160308.
https://doi.org/10.7717/peerj.1753. PMID: 26989609

Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.
Hayakawa Y, Kawada M, Nishikawa H, Ochiya T, Saya H, Seimiya H, Yao R, Hayashi M, Kai C, Matsuda A, Naoe T, Ohtsu A, Okazaki T, Saji H, Sata M, Sugimura H, Sugiyama Y, Toi M, Irimura T.
Cancer Sci. 2016; 107(2): 189-202.
https://doi.org/10.1111/cas.12857. PMID: 26919617

Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.
Sekine S, Pinnow EE, Wu E, Kurtzig R, Hall M, Dal Pan GJ.
Clin Pharmacol Ther. 2016; 100(1): 102-8. Epub 20160331.
https://doi.org/10.1002/cpt.346. PMID: 26853718

Evolving Japanese regulations on companion diagnostics.
Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M.
Nat Biotechnol. 2016; 34(2): 141-4.
https://doi.org/10.1038/nbt.3478. PMID: 26849515

Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians.
Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Yimin C, Kaneko M, Saito Y, Takeuchi M, Watanabe H, Yamazoe Y, Uyama Y, Kawai S.
Br J Clin Pharmacol. 2016; 81(6): 1078-90. Epub 20160314.
https://doi.org/10.1111/bcp.12884. PMID: 26774055

Authors' Reply.
Hirakawa A, Sato H.
Stat Med. 2016; 35(3): 479-80.
https://doi.org/10.1002/sim.6751. PMID: 26757958

2015

Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.
Okada K, Koike K, Sawa Y.
Regen Ther. 2015; 1: 80-3. Epub 20150515.
https://doi.org/10.1016/j.reth.2015.04.001. PMID: 31245444

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms.
Sabol ME, Finkle J, Krucoff M, Stockbridge N, Parkhill N, Shinagawa K, Mahaffey K, Tcheng J, Lenihan D, Melloni C, Todaro T, Michelson E, Munley J, Zander J, Oh R.
Ther Innov Regul Sci. 2015; 49(4): 511-3.
https://doi.org/10.1177/2168479014567319. PMID: 30222439

General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline.
Uyama Y, Yamazaki E, Clark K, Wang CY, Woro E, Tong FY, Sachidanandan S, Rodriguez A, Oh H, Saleh K, Cirunay J, Wapeewuttikorn A, Rogov E, Alshahwan KW, Herrera I, Mthetwa J, Fakudze F, Osawa T.
Ther Innov Regul Sci. 2015; 49(2): 249-53.
https://doi.org/10.1177/2168479014551646. PMID: 30222411

Receptor tyrosine kinase KIT: Prognostic and therapeutic involvement in canine mast cell tumours.
Takeuchi Y, Bonkobara M.
Vet J. 2016; 210: 5-6. Epub 20150729.
https://doi.org/10.1016/j.tvjl.2015.07.012. PMID: 26896296

Randomized study of granulocyte colony stimulating factor for childhood B-cell non-Hodgkin lymphoma: a report from the Japanese pediatric leukemia/lymphoma study group B-NHL03 study.
Tsurusawa M, Watanabe T, Gosho M, Mori T, Mitsui T, Sunami S, Kobayashi R, Fukano R, Tanaka F, Fujita N, Inada H, Sekimizu M, Koh K, Kosaka Y, Komada Y, Saito AM, Nakazawa A, Horibe K.
Leuk Lymphoma. 2016; 57(7): 1657-64. Epub 20151223.
https://doi.org/10.3109/10428194.2015.1106534. PMID: 26694130

Pyrrocidine A, a metabolite of endophytic fungi, has a potent apoptosis-inducing activity against HL60 cells through caspase activation via the Michael addition.
Uesugi S, Fujisawa N, Yoshida J, Watanabe M, Dan S, Yamori T, Shiono Y, Kimura K.
J Antibiot (Tokyo). 2016; 69(3): 133-40. Epub 20151028.
https://doi.org/10.1038/ja.2015.103. PMID: 26506860

Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan.
Handa N, Ishii K, Matsui Y, Ando Y.
EBioMedicine. 2015; 2(9): 1211-6. Epub 20150710.
https://doi.org/10.1016/j.ebiom.2015.07.011. PMID: 26501120

Construction of possible integrated predictive index based on EGFR and ANXA3 polymorphisms for chemotherapy response in fluoropyrimidine-treated Japanese gastric cancer patients using a bioinformatic method.
Takahashi H, Kaniwa N, Saito Y, Sai K, Hamaguchi T, Shirao K, Shimada Y, Matsumura Y, Ohtsu A, Yoshino T, Doi T, Takahashi A, Odaka Y, Okuyama M, Sawada J, Sakamoto H, Yoshida T.
BMC Cancer. 2015; 15: 718. Epub 20151016.
https://doi.org/10.1186/s12885-015-1721-z. PMID: 26475168

Regulatory Frameworks for Gene and Cell Therapies in Japan.
Maeda D, Yamaguchi T, Ishizuka T, Hirata M, Takekita K, Sato D.
Adv Exp Med Biol. 2015; 871: 147-62.
https://doi.org/10.1007/978-3-319-18618-4_8. PMID: 26374217

Accelerating Regulatory Science Initiatives for the Development of Drugs for Alzheimer's Disease in Japan.
Moritoyo T.
Clin Ther. 2015; 37(8): 1622-6.
https://doi.org/10.1016/j.clinthera.2015.04.014. PMID: 26342202

Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.
Hayakawa T, Aoi T, Bravery C, Hoogendoorn K, Knezevic I, Koga J, Maeda D, Matsuyama A, McBlane J, Morio T, Petricciani J, Rao M, Ridgway A, Sato D, Sato Y, Stacey G, Sakamoto N, Trouvin JH, Umezawa A, Yamato M, Yano K, Yokote H, Yoshimatsu K, Zorzi-Morre P.
Biologicals. 2015; 43(5): 283-97. Epub 20150824.
https://doi.org/10.1016/j.biologicals.2015.07.009. PMID: 26315651

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.
Pignatti F, Ashby D, Brass EP, Eichler HG, Frey P, Hillege HL, Hori A, Levitan B, Liberti L, Löfstedt RE, McAuslane N, Micaleff A, Noel RA, Postmus D, Renn O, Sabourin BJ, Salmonson T, Walker S.
Clin Pharmacol Ther. 2015; 98(5): 522-33. Epub 20150911.
https://doi.org/10.1002/cpt.203. PMID: 26261064

How should ethnicity-related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States.
Tanaka A, Asano K, Uyama Y.
Clin Pharmacol Ther. 2015; 98(5): 480-2. Epub 20150905.
https://doi.org/10.1002/cpt.197. PMID: 26250551

Sample Size Considerations in Clinical Trials when Comparing Two Interventions using Multiple Co-Primary Binary Relative Risk Contrasts.
Ando Y, Hamasaki T, Evans SR, Asakura K, Sugimoto T, Sozu T, Ohno Y.
Stat Biopharm Res. 2015; 7(2): 81-94.
https://doi.org/10.1080/19466315.2015.1006373. PMID: 26167243

Atypical Antipsychotics and the Risk of Hyperlipidemia: A Sequence Symmetry Analysis.
Takeuchi Y, Kajiyama K, Ishiguro C, Uyama Y.
Drug Saf. 2015; 38(7): 641-50.
https://doi.org/10.1007/s40264-015-0298-4. PMID: 26001933

General considerations regarding the in vitro and in vivo properties of block copolymer micelle products and their evaluation.
Sakai-Kato K, Nishiyama N, Kozaki M, Nakanishi T, Matsuda Y, Hirano M, Hanada H, Hisada S, Onodera H, Harashima H, Matsumura Y, Kataoka K, Goda Y, Okuda H, Kawanishi T.
J Control Release. 2015; 210: 76-83. Epub 20150513.
https://doi.org/10.1016/j.jconrel.2015.05.259. PMID: 25979322

A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.
Hirakawa A, Wages NA, Sato H, Matsui S.
Stat Med. 2015; 34(24): 3194-213. Epub 20150513.
https://doi.org/10.1002/sim.6533. PMID: 25974405

General considerations in ocular toxicity risk assessment from the toxicologists' viewpoints.
Onodera H, Sasaki S, Otake S, Tomohiro M, Shibuya K, Nomura M.
J Toxicol Sci. 2015; 40(3): 295-307.
https://doi.org/10.2131/jts.40.295. PMID: 25972191

Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.
Kuribayashi R, Matsuhama M, Mikami K.
Aaps j. 2015; 17(5): 1312-6. Epub 20150506.
https://doi.org/10.1208/s12248-015-9777-x. PMID: 25943503

An Antibody-Drug Conjugate Directed against Lymphocyte Antigen 6 Complex, Locus E (LY6E) Provides Robust Tumor Killing in a Wide Range of Solid Tumor Malignancies.
Asundi J, Crocker L, Tremayne J, Chang P, Sakanaka C, Tanguay J, Spencer S, Chalasani S, Luis E, Gascoigne K, Desai R, Raja R, Friedman BA, Haverty PM, Polakis P, Firestein R.
Clin Cancer Res. 2015; 21(14): 3252-62. Epub 20150410.
https://doi.org/10.1158/1078-0432.Ccr-15-0156. PMID: 25862760

Mucosal-associated invariant T cell is a potential marker to distinguish fibromyalgia syndrome from arthritis.
Sugimoto C, Konno T, Wakao R, Fujita H, Fujita H, Wakao H.
PLoS One. 2015; 10(4): e0121124. Epub 20150408.
https://doi.org/10.1371/journal.pone.0121124. PMID: 25853812

New Japanese initiatives on stem cell therapies.
Konomi K, Tobita M, Kimura K, Sato D.
Cell Stem Cell. 2015; 16(4): 350-2.
https://doi.org/10.1016/j.stem.2015.03.012. PMID: 25842974

Clinical Development and Regulatory Approval of Acute Heart Failure Drugs in Japan : Editorial to: "Rationale and Design of Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on Efficacy of Early Initiation of Eplerenone Treatment in Patients with Acute Heart Failure (EARLIER)" by M. Asakura et al.
Shinagawa K.
Cardiovasc Drugs Ther. 2015; 29(2): 107-9.
https://doi.org/10.1007/s10557-015-6579-4. PMID: 25771995

Japanese regulatory authority's perspective on biosimilars.
Nagai S, Yanagihara R, Kishioka Y.
Lancet Oncol. 2015; 16(3): e101.
https://doi.org/10.1016/s1470-2045(14)71220-3. PMID: 25752552

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).
Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW.
J Am Coll Cardiol. 2015; 65(9): 931-41.
https://doi.org/10.1016/j.jacc.2014.12.036. PMID: 25744011

Exposure of drugs for hypertension, diabetes, and autoimmune disease during pregnancy and perinatal outcomes: an investigation of the regulator in Japan.
Sato R, Ikuma M, Takagi K, Yamagishi Y, Asano J, Matsunaga Y, Watanabe H.
Medicine (Baltimore). 2015; 94(1): e386.
https://doi.org/10.1097/md.0000000000000386. PMID: 25569668

2014

Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs.
Ogura T, Morita S, Yonemori K, Nonaka T, Urano T.
Ther Innov Regul Sci. 2014; 48(5): 644-50.
https://doi.org/10.1177/2168479014524582. PMID: 30231453

New Governmental Regulatory System for Stem Cell-Based Therapies in Japan.
Hara A, Sato D, Sahara Y.
Ther Innov Regul Sci. 2014; 48(6): 681-8.
https://doi.org/10.1177/2168479014526877. PMID: 30227468

Multiregional medical device development: regulatory perspective.
Tamura A, Kutsumi H.
Clin J Gastroenterol. 2014; 7(2): 108-16. Epub 20140403.
https://doi.org/10.1007/s12328-014-0478-2. PMID: 26183624

Androgen suppresses the proliferation of androgen receptor-positive castration-resistant prostate cancer cells via inhibition of Cdk2, CyclinA, and Skp2.
Kokontis JM, Lin HP, Jiang SS, Lin CY, Fukuchi J, Hiipakka RA, Chung CJ, Chan TM, Liao S, Chang CH, Chuu CP.
PLoS One. 2014; 9(10): e109170. Epub 20141001.
https://doi.org/10.1371/journal.pone.0109170. PMID: 25271736

Efficacy of RG7787, a next-generation mesothelin-targeted immunotoxin, against triple-negative breast and gastric cancers.
Alewine C, Xiang L, Yamori T, Niederfellner G, Bosslet K, Pastan I.
Mol Cancer Ther. 2014; 13(11): 2653-61. Epub 20140919.
https://doi.org/10.1158/1535-7163.Mct-14-0132. PMID: 25239937

Relationship between drug lag and factors associated with clinical trials in Japan.
Ohwaki K, Nakabayashi T.
J Clin Pharm Ther. 2014; 39(6): 649-52. Epub 20140908.
https://doi.org/10.1111/jcpt.12202. PMID: 25200123

Assessing the prediction accuracy of cure in the Cox proportional hazards cure model: an application to breast cancer data.
Asano J, Hirakawa A, Hamada C.
Pharm Stat. 2014; 13(6): 357-63. Epub 20140716.
https://doi.org/10.1002/pst.1630. PMID: 25044997

Regulation of traditional herbal medicinal products in Japan.
Maegawa H, Nakamura T, Saito K.
J Ethnopharmacol. 2014; 158 Pt B: 511-5. Epub 20140717.
https://doi.org/10.1016/j.jep.2014.07.012. PMID: 25043783

Considerations for non-clinical safety studies of therapeutic peptide vaccines.
Matsumoto M, Komatsu S, Tsuchimoto M, Matsui H, Watanabe K, Nakamura K, Amakasu K, Ito K, Fueki O, Sawada J, Maki K, Onodera H.
Regul Toxicol Pharmacol. 2014; 70(1): 254-60. Epub 20140717.
https://doi.org/10.1016/j.yrtph.2014.06.029. PMID: 25042360

Clinical development and trial design of biosimilar products: a Japanese perspective.
Nagasaki M, Ando Y.
J Biopharm Stat. 2014; 24(6): 1165-72. Epub 20141031
https://doi.org/10.1080/10543406.2014.941983. PMID: 25033370

Considerations for tetanus infection in an adult with a protective tetanus antibody level.
Hifumi T, Yamamoto A, Takahashi M, Koido Y, Kawakita K, Kuroda Y.
Am J Emerg Med. 2014; 32(9): 1125. Epub 20140612.
https://doi.org/10.1016/j.ajem.2014.06.008. PMID: 25027203

Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.
Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei LJ.
J Clin Oncol. 2014; 32(22): 2380-5. Epub 20140630.
https://doi.org/10.1200/jco.2014.55.2208. PMID: 24982461

Representation of older patients in clinical trials for drug approval in Japan.
Asahina Y, Sugano H, Sugiyama E, Uyama Y.
J Nutr Health Aging. 2014; 18(5): 520-3.
https://doi.org/10.1007/s12603-014-0031-5. PMID: 24886739

Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.
Sun H, Vesely R, Nelson RM, Taminiau J, Szitanyi P, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE.
J Pediatr Gastroenterol Nutr. 2014; 58(6): 684-8.
https://doi.org/10.1097/mpg.0000000000000322. PMID: 24866782

Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 1: efficacy endpoints and disease outcome assessments.
Sun H, Vesely R, Taminiau J, Szitanyi P, Papadopoulos EJ, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE.
J Pediatr Gastroenterol Nutr. 2014; 58(6): 679-83.
https://doi.org/10.1097/mpg.0000000000000306. PMID: 24866781

Comparison of statistical analysis plans in randomize-all phase III trials with a predictive biomarker.
Matsui S, Choai Y, Nonaka T.
Clin Cancer Res. 2014; 20(11): 2820-30. Epub 20140401.
https://doi.org/10.1158/1078-0432.Ccr-13-2698. PMID: 24691019

Drug discovery in renal disease--towards a more efficient framework.
Miyata T, Ando T, Hiragi H, Watanabe K, Yamamoto F, Vaughan DE, Kurokawa T, Oshima Y, van Ypersele de Strihou C, Takeuchi M.
Nat Rev Nephrol. 2014; 10(5): 290-6. Epub 20140318.
https://doi.org/10.1038/nrneph.2014.36. PMID: 24642801

Total synthesis of burkholdacs A and B and 5,6,20-tri-epi-burkholdac A: HDAC inhibition and antiproliferative activity.
Fukui Y, Narita K, Dan S, Yamori T, Ito A, Yoshida M, Katoh T.
Eur J Med Chem. 2014; 76: 301-13. Epub 20140218.
https://doi.org/10.1016/j.ejmech.2014.02.044. PMID: 24589486

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.
Kurihara C, Kusuoka H, Ono S, Kakee N, Saito K, Takehara K, Tsujide K, Nabeoka Y, Sakuhiro T, Aoki H, Morishita N, Suzuki C, Kachi S, Kondo E, Komori Y, Isobe T, Kageyama S, Watanabe H.
PLoS One. 2014; 9(1): e84998. Epub 20140108.
https://doi.org/10.1371/journal.pone.0084998. PMID: 24416332

2013

Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011.
Anahara R.
Ther Innov Regul Sci. 2013; 47(4): 424-9.
https://doi.org/10.1177/2168479013489302. PMID: 30235526

The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan.
Asahina Y, Tanaka A, Uyama Y, Kuramochi K, Maruyama H.
Ther Innov Regul Sci. 2013; 47(1): 19-22.
https://doi.org/10.1177/2168479012469950. PMID: 30227480

Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan.
Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y.
Clin Pharmacol Ther. 2014; 95(5): 533-41. Epub 20131108.
https://doi.org/10.1038/clpt.2013.223. PMID: 24213186

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.
Asano K, Tanaka A, Sato T, Uyama Y.
Clin Pharmacol Ther. 2013; 94(2): 195-8.
https://doi.org/10.1038/clpt.2013.106. PMID: 23872835

Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan.
Ishiguro A, Yagi S, Uyama Y.
J Hum Genet. 2013; 58(6): 313-6. Epub 20130509.
https://doi.org/10.1038/jhg.2013.36. PMID: 23657427

Balancing societal needs and regulatory certainty: the case study of peramivir in Japan.
Tominaga T, Ando Y, Nagai N, Sato J, Kondo T.
Clin Pharmacol Ther. 2013; 93(4): 342-4. Epub 20130115.
https://doi.org/10.1038/clpt.2012.268. PMID: 23422872

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.
Otsubo Y, Ishiguro A, Uyama Y.
Pharmacogenomics. 2013; 14(2): 195-203.
https://doi.org/10.2217/pgs.12.194. PMID: 23327579

2012

Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects.
Ando Y, Uyama Y.
J Biopharm Stat. 2012; 22(5): 977-87.
https://doi.org/10.1080/10543406.2012.701581. PMID: 22946944

International vision and strategy for drug regulatory authority: the PMDA's international vision.
Tominaga T, Ando Y, Kondo T.
Clin Pharmacol Ther. 2012; 92(3): 349-51. Epub 20120808.
https://doi.org/10.1038/clpt.2012.90. PMID: 22871996

International models of investigator-initiated trials: implications for Japan.
Trimble EL, Ledermann J, Law K, Miyata T, Imamura CK, Nam BH, Kim YH, Bang YJ, Michaels M, Ardron D, Amano S, Ando Y, Tominaga T, Kurokawa K, Takebe N.
Ann Oncol. 2012; 23(12): 3151-5. Epub 20120725.
https://doi.org/10.1093/annonc/mds168. PMID: 22843420

2011

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions.
McFarland R, Verthelyi D, Casey W, Arciniega J, Isbrucker R, Schmitt M, Finn T, Descamps J, Horiuchi Y, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D.
Procedia Vaccinol. 2011; 5: 16-32. Epub 20111223.
https://doi.org/10.1016/j.provac.2011.10.002. PMID: 32288913

Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels.
Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y.
Drug Metab Pharmacokinet. 2012; 27(1): 142-9. Epub 20111227.
https://doi.org/10.2133/dmpk.dmpk-11-rv-082. PMID: 22201121

An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials.
Hirakawa A.
Stat Med. 2012; 31(6): 516-32. Epub 20111123.
https://doi.org/10.1002/sim.4425. PMID: 22108785

Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan.
Arato T, Yamaguchi T.
Biologicals. 2011; 39(5): 289-92. Epub 20110913.
https://doi.org/10.1016/j.biologicals.2011.08.006. PMID: 21917473

Quality, safety and efficacy of follow-on biologics in Japan.
Yamaguchi T, Arato T.
Biologicals. 2011; 39(5): 328-32. Epub 20110903.
https://doi.org/10.1016/j.biologicals.2011.06.015. PMID: 21890377

Regulatory science as a bridge between science and society.
Tominaga T, Asahina Y, Uyama Y, Kondo T.
Clin Pharmacol Ther. 2011; 90(1): 29-31.
https://doi.org/10.1038/clpt.2011.89. PMID: 21691273

2010

Basic ideas and concepts for multiple comparison procedures.
Takeuchi K.
Biom J. 2010; 52(6): 722-34.
https://doi.org/10.1002/bimj.201000028. PMID: 21154896

Adaptive clinical trials for new drug applications in Japan.
Ando Y, Hirakawa A, Uyama Y.
Eur Neuropsychopharmacol. 2011; 21(2): 175-9. Epub 20101018.
https://doi.org/10.1016/j.euroneuro.2010.09.002. PMID: 20961739

PMDA's challenge to accelerate clinical development and review of new drugs in Japan.
Ichimaru K, Toyoshima S, Uyama Y.
Clin Pharmacol Ther. 2010; 88(4): 454-7.
https://doi.org/10.1038/clpt.2010.190. PMID: 20856242

Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective.
Ando Y, Hamasaki T.
Pharm Stat. 2010; 9(3): 190-200.
https://doi.org/10.1002/pst.448. PMID: 20737442

Participation of elderly patients in registration trials for oncology drug applications in Japan.
Yonemori K, Hirakawa A, Komiyama N, Kouno T, Ando M, Fujiwara Y, Urano T, Akagawa H, Maruyama H, Toyoshima S.
Ann Oncol. 2010; 21(10): 2112-8. Epub 20100323.
https://doi.org/10.1093/annonc/mdq070. PMID: 20332138

Drug interaction studies on new drug applications: current situations and regulatory views in Japan.
Nagai N.
Drug Metab Pharmacokinet. 2010; 25(1): 3-15.
https://doi.org/10.2133/dmpk.25.3. PMID: 20208385

Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.
Ichimaru K, Toyoshima S, Uyama Y.
Clin Pharmacol Ther. 2010; 87(3): 362-6. Epub 20100127.
https://doi.org/10.1038/clpt.2009.285. PMID: 20107436

2008

Current Japanese regulatory situations of pharmacogenomics in drug administration.
Ishiguro A, Toyoshima S, Uyama Y.
Expert Rev Clin Pharmacol. 2008; 1(4): 505-14.
https://doi.org/10.1586/17512433.1.4.505. PMID: 24410553

National GLP programmes and implication of regulatory authorities for pharmaceuticals, pesticides and other chemicals.
Nakashima N.
Ann Ist Super Sanita. 2008; 44(4): 363-8. PMID: 19351997

Immunohistochemical profiles of brain metastases from breast cancer.
Yonemori K, Tsuta K, Shimizu C, Hatanaka Y, Hashizume K, Ono M, Nakanishi Y, Hasegawa T, Miyakita Y, Narita Y, Shibui S, Fujiwara Y.
J Neurooncol. 2008; 90(2): 223-8. Epub 20080723.
https://doi.org/10.1007/s11060-008-9654-x. PMID: 18648908

Assessing the effects of non-steroidal anti-inflammatory drugs on antihypertensive drug therapy using post-marketing surveillance database.
Ishiguro C, Fujita T, Omori T, Fujii Y, Mayama T, Sato T.
J Epidemiol. 2008; 18(3): 119-24. Epub 20080509.
https://doi.org/10.2188/jea.je2007413. PMID: 18469490

2005 to 2007

Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan.
Hori A, Shibata T, Kami M, Kusumi E, Narimatsu H, Kishi Y, Murashige N, Mori K.
Cancer. 2007; 109(12): 2541-6.
https://doi.org/10.1002/cncr.22721. PMID: 17477381

Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan.
Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K.
Clin Pharmacol Ther. 2005; 78(2): 102-13.
https://doi.org/10.1016/j.clpt.2005.04.001. PMID: 16084844

Family bias by proxy.
Ikeda M.
Lancet. 2005; 365(9454): 187.
https://doi.org/10.1016/s0140-6736(05)17710-1. PMID: 15639302