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2024
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C.
Mol Pharm. 2024. Epub 20240930.
https://doi.org/10.1021/acs.molpharmaceut.4c00758. PMID: 39348508
When and how to split the follow-up time in the analysis of epidemiological or clinical studies with follow-ups.
Iwagami M, Ishimaru M, Takeuchi Y, Shinozaki T.
J Epidemiol. 2024. Epub 20240928.
https://doi.org/10.2188/jea.JE20240245. PMID: 39343545
Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.
Matsuda K, Nagai S, Sugimoto K.
Clin Pharmacol Ther. 2024. Epub 20240910.
https://doi.org/10.1002/cpt.3440. PMID: 39253985
Utility of Biomarker-Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making.
Ishiguro A, Kusuhara H, Kimoto E, Miyoshi S, Mizuno K, Hoshino M, Suzuki H.
Clin Pharmacol Ther. 2024. Epub 20240909.
https://doi.org/10.1002/cpt.3436. PMID: 39246046
PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage.
Kajiyama K, Komamine M, Horiuchi N, Iguchi T, Uyama Y.
Pharmacoepidemiol Drug Saf. 2024; 33(9): e70007.
https://doi.org/10.1002/pds.70007. PMID: 39238427
Evaluation of hypermobile teeth deviation during impression taking in a partially edentulous dental arch: An in vitro study comparing digital and conventional impression techniques.
Matsuno H, Wada J, Murakami N, Takakusaki K, Nagayama T, Manabe K, Nomura Y, Koyama S, Mouri Y, Li B, Sakamoto K, Kim EY, Ishioka Y, Utsumi M, Wakabayashi N.
J Prosthodont Res. 2024. Epub 20240903.
https://doi.org/10.2186/jpr.JPR_D_23_00326. PMID: 39231695
Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan.
Shiba T, Aizawa K, Ho M, Ishii K.
Circ J. 2024. Epub 20240904.
https://doi.org/10.1253/circj.CJ-24-0474. PMID: 39231652
Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices.
Ishibashi K, Kondoh M, Kusakabe T.
Ther Innov Regul Sci. 2024. Epub 20240830.
https://doi.org/10.1007/s43441-024-00696-5. PMID: 39212895
Recent progress of Stevens-Johnson syndrome/toxic epidermal necrolysis: Diagnosis criteria, pathogenesis and therapy.
Hama N, Aoki S, Chen CB, Hasegawa A, Ogawa Y, Vocanson M, Asada H, Chu CY, Lan CE, Dodiuk-Gad RP, Fujiyama T, Hsieh TS, Ito K, Jerschow E, Mizukawa Y, Nakajima S, Nakamura K, Nicolas JF, Satoh TK, Shiohara T, Takahashi H, Tohyama M, Ueda T, Ura K, Watanabe H, Yamaguchi Y, Nordmann TM, Chung WH, Naisbitt D, Pincelli C, Pichler WJ, French LE, Phillips E, Abe R.
Br J Dermatol. 2024. Epub 20240814.
https://doi.org/10.1093/bjd/ljae321. PMID: 39141587
Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.
Takakura Y, Hanayama R, Akiyoshi K, Futaki S, Hida K, Ichiki T, Ishii-Watabe A, Kuroda M, Maki K, Miura Y, Okada Y, Seo N, Takeuchi T, Yamaguchi T, Yoshioka Y.
Pharm Res. 2024; 41(8): 1573-94. Epub 20240807.
https://doi.org/10.1007/s11095-024-03757-4. PMID: 39112776
Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline.
Mori K, Aoki Y, Mikashima F, Maki K, Tanaka T, Hayashi M, Sugimoto W, Ono M, Umekita S, Niino T, Fujiwara M, Ebata T, Hirata H, Kojima H.
J Toxicol Sci. 2024; 49(8): 337-48.
https://doi.org/10.2131/jts.49.337. PMID: 39098043
FDA, CDC, and NIH Co-sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.
Hiruy H, Bala S, Byrne JM, Roche KG, Jang SH, Kim P, Nambiar S, Rubin D, Yasinskaya Y, Bachmann LH, Bernstein K, Botgros R, Cammarata S, Chaves RL, Deal CD, Drusano GL, Duffy EM, Eakin AE, Gelone S, Hiltke T, Hook Iii EW, Jerse AE, McNeil CJ, Newman L, O'Brien S, Perry C, Reno HEL, Romaguera RA, Sato J, Unemo M, Wi TEC, Workowski K, O'May GA, Shukla SJ, Farley JJ.
Clin Infect Dis. 2024. Epub 20240724.
https://doi.org/10.1093/cid/ciae386. PMID: 39045871
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; 28(9): 847-65. 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; 24(7): 637-45. Epub 20240709.
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; 21(8): 3697-731. 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; 116(3): 546-62. 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; 58(5): 845-54. 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; 58(5): 831-7. 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.
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Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis.
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Asian J Pharm Sci. 2021; 16(2): 253-62. Epub 20201208.
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PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.
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J Geriatr Oncol. 2021; 12(5): 834-7. Epub 20201231.
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Reliance: a smarter way of regulating medical products - The IPRP survey.
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Expert Rev Clin Pharmacol. 2021; 14(2): 173-7. Epub 20201223.
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Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan.
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Regulatory challenges with biosimilars: an update from 20 countries.
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Maternal DNMT3A-dependent de novo methylation of the paternal genome inhibits gene expression in the early embryo.
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Nat Commun. 2020; 11(1): 5417. Epub 20201027.
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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.
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Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States.
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J Artif Organs. 2021; 24(1): 90-101. Epub 20201020.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan.
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CPT Pharmacometrics Syst Pharmacol. 2020; 9(10): 550-2. Epub 20200911.
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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.
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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.
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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.
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Optimization of the quality by design approach for gene therapy products: A case study for adeno-associated viral vectors.
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Eur J Pharm Biopharm. 2020; 155: 88-102. Epub 20200809.
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A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations.
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Pharm Stat. 2020; 19(6): 975-1000. Epub 20200810.
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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.
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Heart Vessels. 2021; 36(2): 155-62. Epub 20200810.
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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.
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Scientific considerations for global drug development.
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Sci Transl Med. 2020; 12(554).
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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.
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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.
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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.
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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.
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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.
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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.
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First approval of generic dry powder inhaler drug products in Japan.
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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.
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The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
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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.
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Achieving Regulatory Alignment for Anti-Infective Clinical Trials.
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ACS Infect Dis. 2020; 6(6): 1308-10.
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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.
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Pharmaceuticals and Medical Device Agency approval summary: Amenamevir for the treatment of herpes zoster.
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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.
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'All In': a pragmatic framework for COVID-19 testing and action on a global scale.
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EMBO Mol Med. 2020; 12(6): e12634. Epub 20200527.
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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.
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The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
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Biologicals. 2020; 65: 1-9. Epub 20200327.
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Toward global standardization of conducting fair investigations of allegations of research misconduct.
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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.
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Intern Med. 2021; 60(2): 161-6. Epub 20200319.
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Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.
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J Artif Organs. 2020; 23(3): 203-6. Epub 20200228.
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Validation of a new serum granulocyte-macrophage colony-stimulating factor autoantibody testing kit.
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Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents.
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Drug Metab Pharmacokinet. 2020; 35(2): 187-90. Epub 20200118.
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WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
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Biologicals. 2020; 65: 50-9. Epub 20200117.
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Big Data in the Assessment of Pediatric Medication Safety.
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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.
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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.
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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.
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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.
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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.
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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.
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Possible Contribution of Drug Approval Summaries Published by Drug Regulatory Authorities on Scientific Discussion and Drug Development.
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Clin Pharmacol Drug Dev. 2020; 9(1): 6-10. Epub 20191014.
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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.
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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.
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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.
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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.
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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.
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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.
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ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.
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J Am Soc Nephrol. 2019; 30(9): 1772. Epub 20190816.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Pediatric drug regulation: International perspectives.
Baum VC, Bax R, Heon D, Yang Z, Sakiyama M.
Paediatr Anaesth. 2019; 29(6): 572-82. Epub 20190414.
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Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials.
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Pharm Stat. 2019; 18(4): 459-75. Epub 20190305.
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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.
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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.
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Promotion of Japan's participation in global clinical trials.
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Drug Discov Today. 2019; 24(4): 939-42. Epub 20190130.
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A practice of expert review by read-across using QSAR Toolbox.
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Mutagenesis. 2019; 34(1): 49-54.
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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.
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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.
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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.
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AAPS PharmSciTech. 2018; 20(1): 2. Epub 20181217.
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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.
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Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.
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BMC Med. 2018; 16(1): 210. Epub 20181116.
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Antitumor profile of the PI3K inhibitor ZSTK474 in human sarcoma cell lines.
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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.
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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.
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Cell-based chemical fingerprinting identifies telomeres and lamin A as modifiers of DNA damage response in cancer cells.
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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.
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Master protocol trials in oncology: Review and new trial designs.
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Contemp Clin Trials Commun. 2018; 12: 1-8. Epub 20180824.
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Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework.
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Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
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Cryo-EM structures of the human volume-regulated anion channel LRRC8.
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Nat Struct Mol Biol. 2018; 25(9): 797-804. Epub 20180820.
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Determining Food Allergens by Skin Sensitization in Mice.
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Curr Protoc Toxicol. 2018; 76(1): e48. Epub 20180430.
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Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices.
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Clin Exp Nephrol. 2018; 22(6): 1446-75.
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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.
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A Novel Method to Estimate Long-Term Chronological Changes From Fragmented Observations in Disease Progression.
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Regulatory convergence of medical devices: a case study using ISO and IEC standards.
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Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
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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.
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Learning Curve for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System - Initial Analysis of a Japanese Nationwide Registry.
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Freeze-dried equine-derived redback spider antivenom: a local irritation study by intramuscular injection in rabbits and a repeated-dose toxicity study in rats.
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Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.
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Ther Innov Regul Sci. 2019; 53(2): 193-8. Epub 20180502.
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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.
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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.
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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.
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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.
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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.
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Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.
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Cancer Sci. 2016; 107(2): 189-202.
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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.
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Evolving Japanese regulations on companion diagnostics.
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Nat Biotechnol. 2016; 34(2): 141-4.
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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.
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2015
Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.
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Regen Ther. 2015; 1: 80-3. Epub 20150515.
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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.
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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.
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Receptor tyrosine kinase KIT: Prognostic and therapeutic involvement in canine mast cell tumours.
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Vet J. 2016; 210: 5-6. Epub 20150729.
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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.
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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.
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Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan.
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EBioMedicine. 2015; 2(9): 1211-6. Epub 20150710.
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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.
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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.
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Accelerating Regulatory Science Initiatives for the Development of Drugs for Alzheimer's Disease in Japan.
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Clin Ther. 2015; 37(8): 1622-6.
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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.
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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.
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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.
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Clin Pharmacol Ther. 2015; 98(5): 480-2. Epub 20150905.
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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.
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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.
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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.
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A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.
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Stat Med. 2015; 34(24): 3194-213. Epub 20150513.
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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.
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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.
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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.
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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.
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New Japanese initiatives on stem cell therapies.
Konomi K, Tobita M, Kimura K, Sato D.
Cell Stem Cell. 2015; 16(4): 350-2.
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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.
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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.
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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.
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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.
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Multiregional medical device development: regulatory perspective.
Tamura A, Kutsumi H.
Clin J Gastroenterol. 2014; 7(2): 108-16. Epub 20140403.
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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.
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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.
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Relationship between drug lag and factors associated with clinical trials in Japan.
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J Clin Pharm Ther. 2014; 39(6): 649-52. Epub 20140908.
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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.
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Regulation of traditional herbal medicinal products in Japan.
Maegawa H, Nakamura T, Saito K.
J Ethnopharmacol. 2014; 158 Pt B: 511-5. Epub 20140717.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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2013
Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011.
Anahara R.
Ther Innov Regul Sci. 2013; 47(4): 424-9.
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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.
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2012
Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects.
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J Biopharm Stat. 2012; 22(5): 977-87.
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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.
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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.
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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.
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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.
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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.
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Quality, safety and efficacy of follow-on biologics in Japan.
Yamaguchi T, Arato T.
Biologicals. 2011; 39(5): 328-32. Epub 20110903.
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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.
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2010
Polymorphisms of CYP and ethnic differences.
Tateishi T.
Epilepsy & Seizure. 2010; 3(1): 141-6.
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Basic ideas and concepts for multiple comparison procedures.
Takeuchi K.
Biom J. 2010; 52(6): 722-34.
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Adaptive clinical trials for new drug applications in Japan.
Ando Y, Hirakawa A, Uyama Y.
Eur Neuropsychopharmacol. 2011; 21(2): 175-9. Epub 20101018.
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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.
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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.
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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
2009
Future Perspectives for Pharmacovigilance in Japan.
Kawahara A.
J Health Sci. 2009; 55(4): 593-600.
https://doi.org/10.1248/jhs.55.593. 2010000928(医中誌文献番号)
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