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Regulatory Science/The Science Board/Standard Development

Scientific Publications

In this page, information regarding scientific articles to which PMDA members contributed is provided. Please note that it may include views of the author and does not necessarily reflect the official views of PMDA. PMDA encourages the regulatory science research by its staff with various expertise and perspectives for improving the quality of PMDA's services and operations.
Please click the following category (Year).

Table of Contents

 

2024

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 Jun 7. doi: 10.1002/cpt.3316. Online ahead of print.
PMID: 38847597 Review.

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 May 12. doi: 10.1007/s43441-024-00639-0. Online ahead of print.
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 May 10;20(9):536-550. doi: 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 May 6. doi: 10.1007/s43441-024-00660-3. Online ahead of print.
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 May 4:108655. doi: 10.1016/j.pharmthera.2024.108655. Online ahead of print.
PMID: 38710372 Review.

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 May;38(3):225-239. doi: 10.1007/s40290-024-00525-y. Epub 2024 Apr 29.
PMID: 38684588

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 Apr;17(4):e13803. doi: 10.1111/cts.13803.
PMID: 38651283 Free PMC article.

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 Apr 11;6:1353783. doi: 10.3389/ftox.2024.1353783. eCollection 2024.
PMID: 38665214 Free PMC article.

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 Apr;17(4):e13803. doi: 10.1111/cts.13803.
PMID: 38651283 Free PMC article.

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 Jun;44(2):308-313. doi: 10.1002/npr2.12436. Epub 2024 Apr 16.
PMID: 38624143 Free PMC article. Review.

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 Apr 15;25(1):134. doi: 10.1186/s12882-024-03553-7.
PMID: 38622507 Free PMC article.

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 Mar 21;27:12398. doi: 10.3389/jpps.2024.12398. eCollection 2024.

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 Apr 4. doi: 10.1007/s43441-024-00649-y. Online ahead of print.

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 Feb 14;2024:9331738. doi: 10.1155/2024/9331738. eCollection 2024.

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). 2024 Jan 24;10:1294696. doi: 10.3389/fmed.2023.1294696. eCollection 2023.

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 Jan 26;19(1):e0297679. doi: 10.1371/journal.pone.0297679. eCollection 2024.

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 May;115(5):965-970. doi: 10.1002/cpt.3163. Epub 2024 Jan 22.
PMID: 38251824 Review.

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 Mar;115(3):412-421. doi: 10.1002/cpt.3133. Epub 2023 Dec 18.
PMID: 38069528 Review.

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 Oct 30;23(1):242. doi: 10.1186/s12911-023-02345-7.

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 Jan;58(1):192-199. doi: 10.1007/s43441-023-00586-2. Epub 2023 Oct 29.

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 Oct 5;23(1):203. doi: 10.1186/s12911-023-02303-3.

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; Japanese Urological Oncology Group.
Urol Oncol. 2023 Oct 3:S1078-1439(23)00286-7. doi: 10.1016/j.urolonc.2023.08.008. Online ahead of print.

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 Sep 11;12(18):5888. doi: 10.3390/jcm12185888.

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 Sep 15:10915818231200859. doi: 10.1177/10915818231200859. Online ahead of print.

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 Dec;59:23-27. doi: 10.1016/j.jdsr.2023.01.001. Epub 2023 Feb 7.

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 Aug 25;38:100885. doi: 10.1016/j.lanwpc.2023.100885. eCollection 2023 Sep.

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 Aug 16. doi: 10.1007/s43441-023-00566-6. Online ahead of print.

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 Aug 14;77(3):380-387. doi: 10.1093/cid/ciad195.

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 Feb;51(1):5-31. doi: 10.1007/s10928-023-09878-4. Epub 2023 Aug 13.

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 Aug 3. doi: 10.1002/cpt.3006. Online ahead of print.

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 Aug 3;28(8):664-670. doi: 10.1093/oncolo/oyad041.

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 Aug;142:105413. doi: 10.1016/j.yrtph.2023.105413. Epub 2023 May 23.

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 Aug;16(8):1289-1293. doi: 10.1111/cts.13536. Epub 2023 May 10.

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 Jul;29:220-225. doi: 10.1016/j.jtos.2023.05.008. Epub 2023 May 29.
PMID: 37257692 Review.

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 Jul;37(4):443-451. doi: 10.1007/s40259-023-00605-6. Epub 2023 May 25.

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 Jul;52:67-74. doi: 10.1016/j.carrev.2023.02.015. Epub 2023 Feb 24.

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 Jun 29;53(7):619-628. doi: 10.1093/jjco/hyad033.

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 Jun 20;147(25):1933-1944. doi: 10.1161/CIRCULATIONAHA.123.064473. Epub 2023 Jun 19.

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 Jun 15. doi: 10.1111/iju.15226. Online ahead of print.

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 Jun;43(2):172-176. doi: 10.1002/npr2.12339. Epub 2023 Apr 14.

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 May 26. doi: 10.1097/CCM.0000000000005941. Online ahead of print.

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 May;30(5):447-454. doi: 10.1111/iju.15152. Epub 2023 Feb 14.

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 Apr 17;10:1141880. doi: 10.3389/fmed.2023.1141880. eCollection 2023.

Challenges in Expediting the Development of Oncology Drugs.
Noguchi E, Yaginuma H, Fujiwara Y.
JCO Oncol Pract. 2023 Apr;19(4):216-217. doi: 10.1200/OP.22.00705. Epub 2023 Jan 19.

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 Apr;113(4):924-931. doi: 10.1002/cpt.2850. Epub 2023 Jan 31.

Practical basket design for binary outcomes with control of family-wise error rate.
Asano J, Sato H, Hirakawa A.
BMC Med Res Methodol. 2023 Feb 27;23(1):52. doi: 10.1186/s12874-023-01872-1.
Clinical Trial.

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 Feb 23;10:1096992. doi: 10.3389/fmed.2023.1096992. eCollection 2023.

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. 2023 Jan 9;13:1091386. doi: 10.3389/fpsyt.2022.1091386. eCollection 2022.

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;1430:155-179. doi: 10.1007/978-3-031-34567-8_9.

2022

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. 2022 Dec 23;4:100100. doi: 10.1016/j.crtox.2022.100100. eCollection 2023.

Clinical Practice Guidelines in Cardio-Oncology: A Sea of Opportunity.
Sase K, Mukai M, Fujiwara Y.
JACC CardioOncol. 2022 Dec 6;5(1):145-148. doi: 10.1016/j.jaccao.2022.11.001. eCollection 2023 Feb.

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. doi: 10.1002/pds.5507. Epub 2022 Oct 10.

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. doi: 10.1007/s43441-022-00437-6. Epub 2022 Aug 13.

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. doi: 10.1002/psp4.12868. Epub 2022 Oct 5.

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. doi: 10.1007/s10067-022-06305-w. Epub 2022 Aug 16.

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. doi: 10.1253/circj.CJ-22-0185. Epub 2022 Sep 1.

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. 2022 Nov 20. doi: 10.1002/cpt.2788.

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. 2022 Nov 17. doi: 10.1111/joa.13790.

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. 2022 Nov 1. doi: 10.1111/cts.13439.

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. doi: 10.1016/j.toxlet.2022.09.005. Epub 2022 Sep 12.

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. doi: 10.1007/s43441-022-00409-w. Epub 2022 Apr 26.

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. 2022 Oct 30:1-14. doi: 10.1007/s43441-022-00466-1.

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 Oct 26;22(1):1292. doi: 10.1186/s12913-022-08685-w.

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. doi: 10.1016/j.vaccine.2022.09.036. Epub 2022 Sep 24.

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 Oct;25(10):1663-1672. doi: 10.1016/j.jval.2022.09.001.

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 Sep 21;27:100600. doi: 10.1016/j.lanwpc.2022.100600.

Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses.
Yamamoto H, Suzuki H.
EClinicalMedicine. 2022 Aug 26;52:101601. doi: 10.1016/j.eclinm.2022.101601.

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. 2022 Sep 13. doi: 10.1007/s43441-022-00457-2.

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 Jul;15(7):805-810. doi: 10.1080/17512433.2022.2088503.

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. doi: 10.1007/s00774-022-01328-4. Epub 2022 May 12.

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. doi: 10.1007/s43441-022-00400-5. Epub 2022 Apr 18.

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; CRITICAL Study Group Investigators.
Heart Vessels. doi: 10.1007/s00380-022-02020-3. Epub 2022 Jan 19.

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 Mar 29;23:100442. doi: 10.1016/j.lanwpc.2022.100442.

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 May;9(5):e374-e384. doi: 10.1016/S2352-3026(22)00045-X.

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 May 1;182(5):569-570. doi: 10.1001/jamainternmed.2022.0102.

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. doi: 10.1007/s43441-022-00381-5. Epub 2022 Feb 18.

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. doi: 10.1016/j.vaccine.2022.03.043. Epub 2022 Mar 24.

Early Treatment with Sotrovimab for Covid-19.
Fujiwara Y.
N Engl J Med. doi: 10.1056/NEJMc2201606. Epub 2022 Mar 16.

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; following participants of the WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, 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; Other participants; Representatives of the Developing Countries Vaccine Manufacturers Network; Representatives of the Emerging Biopharmaceutical Manufacturers Network; Representatives of the IFPMA; Representatives of IGBA; Representative of the Latin American Association of Pharmaceutical Industries; Representative of the Singapore Association of Pharmaceutical Industries; WHO Secretariat.
Biologicals. doi: 10.1016/j.biologicals.2022.03.001. Epub 2022 Apr 22.

2021

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. doi: 10.1016/j.carrev.2021.08.020. Epub 2021 Sep 1.

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. doi: 10.1007/s43441-021-00350-4. Epub 2021 Nov 17.

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. doi: 10.1111/bcp.15065. Epub 2021 Sep 15.

The PMDA Perspectives on New Oral Prolyl Hydroxylase Domain Enzyme Inhibitors for Renal Anemia.
Tanaka M, Ikuma M, Asakura W, Fujiwara Y.
Clin Pharmacol Ther. doi: 10.1002/cpt.2275. Epub 2021 May 16.

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. doi: 10.1002/cpt.2410. Epub 2021 Sep 18.

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. doi: 10.1007/s43441-021-00332-6. Epub 2021 Aug 18.

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. doi: 10.1016/j.dmpk.2021.100414. Epub 2021 Jul 8.

Orphan drug designation and development in Japan: 25 years of experience and assessment.
Sakushima K, Takeda H, Aoi Y.
Nat Rev Drug Discov. 2021 Dec;20(12):893-894. doi: 10.1038/d41573-021-00045-3.

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 Nov 24;11:732525. doi: 10.3389/fonc.2021.732525.

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. doi: 10.1007/s13318-021-00720-1. Epub 2021 Sep 29.

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. doi: 10.1007/s40264-021-01104-9. Epub 2021 Aug 4.

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. doi: 10.1111/cts.13098. Epub 2021 Jul 14.

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 Oct 11;8:756870. doi: 10.3389/fmed.2021.756870.

Achievements and challenges of the Sakigake designation system in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. doi: 10.1111/bcp.14807. Epub 2021 Mar 22.

Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis.
Ezaki A, Hirakawa A, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. doi: 10.1007/s43441-021-00309-5. Epub 2021 Jun 9.

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; Guidance Development Committee for Clinical Trial Protocols for Chronic Wound Treatment Medical Devices.
J Wound Care. 2021 Aug 2;30(8):666-676. doi: 10.12968/jowc.2021.30.8.666.

Nested Case-Control Study Utilizing MID-NET® on Thrombocytopenia Associated With Pegfilgrastim in Patients Treated With Antineoplastic Agents.
Kajiyama K, Ishiguro C, Ando T, Kubota Y, Kinoshita N, Oniyama Y, Iguchi T, Uyama Y.
Clin Pharmacol Ther. doi: 10.1002/cpt.2263. Epub 2021 May 19.

Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. doi: 10.1111/bcp.14749. Epub 2021 Mar 5.

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 Jul 15;11(7):e043768. doi: 10.1136/bmjopen-2020-043768.

The PMDA's view on the limited pipeline of nephrology drugs in Japan.
Tanaka M, Ikuma M.
Kidney Int. 2021 Jul;100(1):241-242. doi: 10.1016/j.kint.2021.03.034.

Guidelines for clinical evaluation of anti-cancer drugs.
Minami H, Kiyota N, Kimbara S, Ando Y, Shimokata T, Ohtsu A, Fuse N, Kuboki Y, Shimizu T, Yamamoto N, Nishio K, Kawakami Y, Nihira SI, Sase K, Nonaka T, Takahashi H, Komori Y, Kiyohara K.
Cancer Sci. doi: 10.1111/cas.14967. Epub 2021 Jun 8.

Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma.
Kanno H, Nagata H, Ishiguro A, Tsuzuranuki S, Nakano S, Nonaka T, Kiyohara K, Kimura T, Sugawara A, Okazaki Y, Takae S, Nakabayashi T, Arai H, Suzuki H.
Oncologist. doi: 10.1002/onco.13805. Epub 2021 May 18.

Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic.
Chong SSF, Kim M, Limoli M, Obscherning E, Wu P, Feisee L, Nakashima N, Lim JCW.
Ther Innov Regul Sci. doi: 10.1007/s43441-021-00285-w. Epub 2021 Apr 11.

Characteristics of hospital differences in missing of clinical laboratory test results in a multi-hospital observational database contributing to MID-NET® in Japan.
Komamine M, Fujimura Y, Nitta Y, Omiya M, Doi M, Sato T.
BMC Med Inform Decis Mak. 2021 Jun 6;21(1):181. doi: 10.1186/s12911-021-01543-5.

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.
Wakao R, Lönnstedt IM, Aoki Y, Chandler RE.
Drug Saf. doi: 10.1007/s40264-021-01063-1. Epub 2021 Apr 10.

No-fault compensation schemes for COVID-19 medical products.
Fujiwara Y, Onda Y, Hayashi S.
Lancet. 2021 May 8;397(10286):1707-1708. doi: 10.1016/S0140-6736(21)00784-4.

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

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

Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.
Hata T, Nakamura K, Yonemori K, Noguchi E, Watanabe M, Sohn J, Lu YS, Yap YS, Tamura K, Fujiwara Y.
Clin Transl Sci. doi: 10.1111/cts.12965. Epub 2021 Mar 1.

Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals.
Hirabayashi Y, Maki K, Kinoshita K, Nakazawa T, Obika S, Naota M, Watanabe K, Suzuki M, Arato T, Fujisaka A, Fueki O, Ito K, Onodera H.
Nucleic Acid Ther. doi: 10.1089/nat.2020.0879. Epub 2021 Jan 19.

Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region.
Tanemura N, Sasaki T, Sato J, Urushihara H.
Trials. 2021 Mar 12;22(1):204. doi: 10.1186/s13063-021-05143-6.

Pediatric Medical Devices - Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan.
Miyoshi T, Kato A, Yasukochi S, Takahashi S, Ho M, Yamamoto H, Inuzuka R, Kim SH, Sakamoto K, Kobayashi T.
Circ Rep. 2021 Jan 26;3(3):153-160. doi: 10.1253/circrep.CR-20-0136.

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies.
Wang SV, Pinheiro S, Hua W, Arlett P, Uyama Y, Berlin JA, Bartels DB, Kahler KH, Bessette LG, Schneeweiss S.
BMJ. 2021 Jan 12;372:m4856. doi: 10.1136/bmj.m4856.

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;24:548-562. doi: 10.18433/jpps32260.

2020

Efficacy and safety of second-line axitinib in octogenarians with metastatic renal cell carcinoma.
Nakai Y, Takeuchi A, Osawa T, Kojima T, Hara T, Sugimoto M, Eto M, Minami K, Ueda K, Ozawa M, Uemura M, Miyauchi Y, Ohba K, Kashiwagi A, Murakami M, Sazuka T, Yasumoto H, Morizane S, Kawasaki Y, Morooka D, Shimazui T, Yamamoto Y, Nakagomi H, Tomida R, Ito YM, Murai S, Kitamura H, Nishiyama H, Shinohara N; Japanese Urological Oncology Group.
J Geriatr Oncol. doi: 10.1016/j.jgo.2020.12.012. Epub 2020 Dec 31.

Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan.
Asano K, Aoi Y, Kamada S, Uyama Y, Tohkin M.
Clin Pharmacol Ther. doi: 10.1002/cpt.2121. Epub 2020 Dec 16.

Regulatory challenges with biosimilars: an update from 20 countries.
Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, Chua HM, Dalili D, Foo F, Gao K, Habahbeh S, Hamel H, Kim GH, Perez Rodriguez V, Putri DE, Rodgers J, Savkina M, Semeniuk O, Srivastava S, Tavares Neto J, Wadhwa M, Yamaguchi T.
Ann N Y Acad Sci. doi: 10.1111/nyas.14522. Epub 2020 Nov 21.

Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass in adult patients undergoing cardiac surgery.
Asada M, Nagata M, Mizuno T, Uchida T, Takahashi H, Makita K, Arai H, Kijima S, Echizen H, Yasuhara M.
Eur J Clin Pharmacol. doi: 10.1007/s00228-020-03045-1. Epub 2020 Nov 19.

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. doi: 10.1002/cpt.2080. Epub 2020 Nov 15.

Balancing Safety and Efficacy With Early Availability in the Regulation of Regenerative Medicine Product.
Fujiwara Y, Maruyama Y, Honda F.
Clin Pharmacol Ther. doi: 10.1002/cpt.2034. Epub 2020 Sep 26.

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. doi: 10.1002/cpt.2045. Epub 2020 Oct 8.

Control strategy and methods for continuous direct compression processes.
Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, Mano E, Motoyama K, Koide T, Matsui Y, Kurasaki K, Takayama I, Hikage S, Katori N, Kikuchi M, Sakai H, Matsuda Y.
Asian J Pharm Sci. doi: 10.1016/j.ajps.2020.11.005. Epub 2020 Dec 8.

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States.
Takahashi S, Iwasaki K, Shirato H, Ho M, Umezu M.
J Artif Organs. doi: 10.1007/s10047-020-01216-6. Epub 2020 Oct 20.

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. doi: 10.1200/OP.20.00131. Epub 2020 Sep 21.

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. doi: 10.1007/s43441-020-00215-2. Epub 2020 Sep 11.

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.
Shimokawa M, Sato D, Wakao R, Arai H.
Clin Pharmacol Ther. doi: 10.1002/cpt.1986. Epub 2020 Aug 18.

Reliance: a smarter way of regulating medical products - The IPRP survey.
Doerr P, Valentin M, Nakashima N, Orphanos N, Santos G, Balkamos G, Saint-Raymond A.
Expert Rev Clin Pharmacol. doi: 10.1080/17512433.2021.1865798. Epub 2020 Dec 23.

Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing.
Ishimoto H, Kano M, Sugiyama H, Takeuchi H, Terada K, Aoyama A, Shoda T, Demizu Y, Shimamura J, Yokoyama R, Miyamoto Y, Hasegawa K, Serizawa M, Unosawa K, Osaki K, Asai N, Matsuda Y.
Chem Pharm Bull (Tokyo). doi: 10.1248/cpb.c20-00824. Epub 2020 Dec 8.

Modernization and Strengthening of Bioequivalence Guidelines in Japan.
Kuribayashi R, Yamaguchi T, Takagi K.
Clin Pharmacokinet. doi: 10.1007/s40262-020-00965-0. Epub 2020 Nov 28.

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A.
J Pharm Sci. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3.

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint.
Mitsutake Y, Konishi A, Shiba T, Ito T, Ho M, Shirato H.
Heart Vessels. doi: 10.1007/s00380-020-01676-z. Epub 2020 Aug 10.

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.
Konishi A, Ho M, Mitsutake Y, Ouchi T, Nakamura M, Shirato H.
Intern Med. doi: 10.2169/internalmedicine.4286-19. Epub 2020 Mar 19.

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 Dec;45(6):697-702. doi: 10.1007/s13318-020-00646-0.

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 Nov;40(11):6171-6178. doi: 10.21873/anticanres.14637.

Role of Roxadustat for ESA-Resistant Renal Anemia? -Read with Caution.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. doi: 10.1681/ASN.2020060821. Epub 2020 Sep 4.

A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations.
Asano J, Hirakawa A.
Pharm Stat. doi: 10.1002/pst.2049. Epub 2020 Aug 10.

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting.
Iwasa E, Fujiyoshi Y, Kubota Y, Kimura R, Chandler RE, Taavola H, Norén GN, Wakao R.
Drug Saf. 2020 Nov;43(11):1121-1131. doi: 10.1007/s40264-020-00968-7.

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. doi: 10.1007/s43441-020-00180-w. Epub 2020 Jun 10.

Maternal DNMT3A-dependent de novo methylation of the paternal genome inhibits gene expression in the early embryo.
Richard Albert J, Au Yeung WK, Toriyama K, Kobayashi H, Hirasawa R, Brind'Amour J, Bogutz A, Sasaki H, Lorincz M.
Nat Commun. 2020 Oct 27;11(1):5417. doi: 10.1038/s41467-020-19279-7.

Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan.
Kijima S, Ochiai Y, Ishiguro A.
CPT Pharmacometrics Syst Pharmacol. doi: 10.1002/psp4.12554. Epub 2020 Sep 11.

Optimization of the quality by design approach for gene therapy products: A case study for adeno-associated viral vectors.
Tanaka T, Hanaoka H, Sakurai S.
Eur J Pharm Biopharm. doi: 10.1016/j.ejpb.2020.08.002. Epub 2020 Aug 9.

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. doi: 10.1089/hum.2020.156. Epub 2020 Sep 17.

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 Oct;13(5):623-632. doi: 10.1007/s40271-020-00436-5.

First approval of generic dry powder inhaler drug products in Japan.
Kuribayashi R, Myoenzono A.
Drug Deliv Transl Res. 2020 Oct;10(5):1517-1519. doi: 10.1007/s13346-020-00817-1.

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. 2doi: 10.1016/j.alit.2020.04.006. Epub 2020 Jun 27.

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 Sep 22;76(12):1468-1483. doi: 10.1016/j.jacc.2020.06.085.

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. doi: 10.1161/CIRCULATIONAHA.120.047232. Epub 2020 Sep 14.

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 Sep 5;50(9):970-975. doi: 10.1093/jjco/hyaa121.

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. doi: 10.1111/cas.14564. Epub 2020 Jul 28.

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.
Handa N, Mochizuki S, Fujiwara Y, Shimokawa M, Wakao R, Arai H.
J Artif Organs. doi: 10.1007/s10047-020-01161-4. Epub 2020 Feb 28.

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System.
Mitsutake Y, Konishi A, Handa N, Ho M, Shirato H, Ito T, Koike K, Mochizuki S, Ishii K.
Circ J. doi: 10.1253/circj.CJ-20-0133. Epub 2020 Jul 17.

Boosting delivery of rare disease therapies: the IRDiRC Orphan Drug Development Guidebook.
Hechtelt Jonker A, Hivert V, Gabaldo M, Batista L, O'Connor D, Aartsma-Rus A, Day S, Sakushima K, Ardigo D.
Nat Rev Drug Discov. 2020 Aug;19(8):495-496. doi: 10.1038/d41573-020-00060-w.

Toward global standardization of conducting fair investigations of allegations of research misconduct.
Nouchi R, Aihara H, Arie F, Asashima M, Daida H, Fudano J, Fujiwara Y, Fushiki S, Geller RJ, Hatano K, Homma T, Kimura M, Kuroki T, Miki K, Morita I, Nitta K, Shinohara A, Siomi MC, Yoshida M, Ichikawa I.
Account Res. doi: 10.1080/08989621.2020.1747019. Epub 2020 May 12.

Scientific considerations for global drug development.
Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN, Lee HA, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, Lumpkin MM, Giacomini KM, Blaschke TF.
Sci Transl Med. 2020 Jul 29;12(554):eaax2550. doi: 10.1126/scitranslmed.aax2550.

A Potential Mechanism of Tumor Progression during Systemic Infections Via the Hepatocyte Growth Factor (HGF)/c-Met Signaling Pathway.
Tsujimoto H, Horiguchi H, Matsumoto Y, Takahata R, Shinomiya N, Yamori T, Miyazaki H, Ono S, Saitoh D, Kishi Y, Ueno H.
J Clin Med. 2020 Jul 1;9(7):2074. doi: 10.3390/jcm9072074.

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; Japanese Urological Oncology Group.
Cancer Sci. doi: 10.1111/cas.14449. Epub 2020 Jun 12.

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; ACE Consensus Group.
BMJ. 2020 Jun 17;369:m115. doi: 10.1136/bmj.m115.


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; ACE Consensus Group.
Trials. 2020 Jun 17;21(1):528. doi: 10.1186/s13063-020-04334-x.

Achieving Regulatory Alignment for Anti-Infective Clinical Trials.
Nambiar S, Cavaleri M, Sato J.
ACS Infect Dis. 2020 Jun 12;6(6):1308-1310. doi: 10.1021/acsinfecdis.0c00270.

'All In': a pragmatic framework for COVID-19 testing and action on a global scale.
Pettit SD, Jerome KR, Rouquié D, Mari B, Barbry P, Kanda Y, Matsumoto M, Hester S, Wehmas L, Botten JW, Bruce EA.
EMBO Mol Med. doi: 10.15252/emmm.202012634. Epub 2020 May 27.

Evaluation of reoperations for removal of bioabsorbable plates and screws based on adverse events reports from PMDA, Japan.
Kobayashi T, Handa N, Koike K, Mochizuki S, Kaku I, Takae S.
BMJ Surg Interv Health Technol. 2020 May 6;2(1):e000033. doi: 10.1136/bmjsit-2020-000033.

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
Kang HN, Thorpe R, Knezevic I; Survey participants from 19 countries.
Biologicals. doi: 10.1016/j.biologicals.2020.02.005. Epub 2020 Mar 27.

WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T; WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Andalucia LR, Blades CDRZ, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M.
Biologicals. doi: 10.1016/j.biologicals.2019.12.008. Epub 2020 Jan 17.

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; Harmonization by Doing for Children Working Group.
Circ J. doi: 10.1253/circj.CJ-19-1092. Epub 2020 Apr 1.

Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents.
Tohkin M, Saito Y, Yagi S, Asano K, Maekawa K, Osabe M, Iida S, Miyata N.
Drug Metab Pharmacokinet. doi: 10.1016/j.dmpk.2020.01.003. Epub 2020 Jan 18.

Big Data in the Assessment of Pediatric Medication Safety.
McMahon AW, Cooper WO, Brown JS, Carleton B, Doshi-Velez F, Kohane I, Goldman JL, Hoffman MA, Kamaleswaran R, Sakiyama M, Sekine S, Sturkenboom MCJM, Turner MA, Califf RM.
Pediatrics. doi: 10.1542/peds.2019-0562. Epub 2020 Jan 14.

Validation of a new serum granulocyte-macrophage colony-stimulating factor autoantibody testing kit.
Nakata K, Sugi T, Kuroda K, Yoshizawa K, Takada T, Tazawa R, Ueda T, Aoki A, Abe M, Tatsumi K, Eda R, Kondoh S, Morimoto K, Tanaka T, Yamaguchi E, Takahashi A, Oda M, Ishii H, Izumi S, Sugiyama H, Nakagawa A, Tomii K, Suzuki M, Konno S, Ohkouchi S, Hirano T, Handa T, Hirai T, Inoue Y, Arai T, Asakawa K, Sakagami T, Tanaka T, Mikami A, Kitamura N.
ERJ Open Res. 2020 Jan 27;6(1):00259-2019. doi: 10.1183/23120541.00259-2019.

2019

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. doi: 10.1007/s43441-019-00003-7. Epub 2019 Dec 5.

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; International Neonatal Consortium.
J Pediatr. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8.

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. doi: 10.1016/j.jjcc.2019.07.016. Epub 2019 Sep 17.

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. doi: 10.1016/j.dmpk.2019.11.009. Epub 2019 Dec 20.

Possible Contribution of Drug Approval Summaries Published by Drug Regulatory Authorities on Scientific Discussion and Drug Development.
Tanese K, Yamori T.
Clin Pharmacol Drug Dev. doi: 10.1002/cpdd.744. Epub 2019 Oct 14.

Function of Prion Protein and the Family Member, Shadoo.
Onodera T, Nishimura T, Sugiura K, Sakudo A.
Curr Issues Mol Biol. doi: 10.21775/cimb.036.067. Epub 2019 Sep 27.

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. doi: 10.1002/cpt.1604. Epub 2019 Sep 13.

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 Dec;42(12):1487-1498. doi: 10.1007/s40264-019-00861-y.

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 Dec;44(6):743-745. doi: 10.1007/s13318-019-00561-z.

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 Oct 14;34(39):e255. doi: 10.3346/jkms.2019.34.e255.

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. doi: 10.1016/j.vaccine.2019.08.031. Epub 2019 Sep 7.

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. doi: 10.1002/pds.4879. Epub 2019 Aug 29.

ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. doi: 10.1681/ASN.2019060556. Epub 2019 Aug 16.

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. doi: 10.1002/pds.4847. Epub 2019 Jul 23.

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 Aug 21;264:1498-1499. doi: 10.3233/SHTI190503.

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 Aug 14;1(1):e000014. doi: 10.1136/bmjsit-2019-000014.

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 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372.

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. doi: 10.1016/j.dmpk.2019.04.006. Epub 2019 Apr 24.

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. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22.

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. doi: 10.1002/pds.4837. Epub 2019 Jun 13.

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. doi: 10.1016/j.jjcc.2019.03.013. Epub 2019 Apr 17.

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials.
Nonaka T, Igeta M, Matsui S.
Pharm Stat. doi: 10.1002/pst.1937. Epub 2019 Mar 5.

Pediatric drug regulation: International perspectives.
Baum VC, Bax R, Heon D, Yang Z, Sakiyama M.
Paediatr Anaesth. doi: 10.1111/pan.13638. Epub 2019 Apr 14.

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. doi: 10.1111/bcp.13893. Epub 2019 Mar 28.

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. doi: 10.1002/cpt.1342. Epub 2019 Feb 10.

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; MID-NET® project group.
Pharmacoepidemiol Drug Saf. doi: 10.1002/pds.4777. Epub 2019 Apr 3.

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. doi: 10.1007/s10157-018-01684-4. Epub 2019 Jan 28.

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. doi: 10.1007/s10157-019-01695-9. Epub 2019 Jan 28.

Oseltamivir phosphate-Lifting the restriction on its use to treat teenagers with influenza in Japan.
Takeuchi S, Tetsuhashi M, Sato D.
Pharmacoepidemiol Drug Saf. doi: 10.1002/pds.4721. Epub 2019 Mar 4.

Promotion of Japan's participation in global clinical trials.
Kondo H, Shimada Y, Ozawa T.
Drug Discov Today. doi: 10.1016/j.drudis.2019.01.016. Epub 2019 Jan 30.

A practice of expert review by read-across using QSAR Toolbox.
Fukuchi J, Kitazawa A, Hirabayashi K, Honma M.
Mutagenesis. 2019 Mar 6;34(1):49-54. doi: 10.1093/mutage/gey046.

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):1301-1313. doi: 10.1248/cpb.c19-00621.

2018

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework.
Tsukamoto K, Cnop M, Mori D, Kume S, Anazawa T, Doi M, Chikazawa K, Matsumaru N.
Ther Innov Regul Sci. doi: 10.1177/2168479018795854. Epub 2018 Sep 3.

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.
Kondo H, Shibatsuji M, Yasuda N.
Ther Innov Regul Sci. doi: 10.1177/2168479018771312. Epub 2018 May 2.

A Novel Method to Estimate Long-Term Chronological Changes From Fragmented Observations in Disease Progression.
Ishida T, Tokuda K, Hisaka A, Honma M, Kijima S, Takatoku H, Iwatsubo T, Moritoyo T, Suzuki H; Alzheimer's Disease Neuroimaging Initiative.
Clin Pharmacol Ther. doi: 10.1002/cpt.1166. Epub 2018 Aug 20.

Critical roles of inflammation in atherosclerosis.
Moriya J.
J Cardiol. doi: 10.1016/j.jjcc.2018.05.010. Epub 2018 Jun 12.

Global Regulatory Landscape.
Matsuda Y.
AAPS PharmSciTech. 2018 Dec 17;20(1):2. doi: 10.1208/s12249-018-1230-x.

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 Dec;4:1-11. doi: 10.1200/JGO.18.00092.

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. doi: 10.1016/j.ahj.2018.08.017. Epub 2018 Sep 7.

Master protocol trials in oncology: Review and new trial designs.
Hirakawa A, Asano J, Sato H, Teramukai S.
Contemp Clin Trials Commun. 2018 Aug 24;12:1-8. doi: 10.1016/j.conctc.2018.08.009.

Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices.
Kanda E, Kashihara N, Matsushita K, Usui T, Okada H, Iseki K, Mikami K, Tanaka T, Wada T, Watada H, Ueki K, Nangaku M; Research Working Group for Establishing Guidelines for Clinical Evaluation of Chronic Kidney Disease.
Clin Exp Nephrol. 2018 Dec;22(6):1446-1475. doi: 10.1007/s10157-018-1615-x.

Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective - Reply.
Yokoi H, Ho M, Iwamoto S; (on behalf of the authors).
Circ J. doi: 10.1253/circj.CJ-18-1066. Epub 2018 Oct 30.

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

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.
Watanabe K, Murakami M, Masuyama K, Ishiguro C, Matsuda T.
Pharmacoepidemiol Drug Saf. doi: 10.1002/pds.4662. Epub 2018 Sep 25.

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM.
Lancet Haematol. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18.

Antitumor profile of the PI3K inhibitor ZSTK474 in human sarcoma cell lines.
Namatame N, Tamaki N, Yoshizawa Y, Okamura M, Nishimura Y, Yamazaki K, Tanaka M, Nakamura T, Semba K, Yamori T, Yaguchi SI, Dan S.
Oncotarget. 2018 Oct 12;9(80):35141-35161. doi: 10.18632/oncotarget.26216.

Cell-based chemical fingerprinting identifies telomeres and lamin A as modifiers of DNA damage response in cancer cells.
Fujiwara C, Muramatsu Y, Nishii M, Tokunaka K, Tahara H, Ueno M, Yamori T, Sugimoto Y, Seimiya H.
Sci Rep. 2018 Oct 4;8(1):14827. doi: 10.1038/s41598-018-33139-x.

Cryo-EM structures of the human volume-regulated anion channel LRRC8.
Kasuya G, Nakane T, Yokoyama T, Jia Y, Inoue M, Watanabe K, Nakamura R, Nishizawa T, Kusakizako T, Tsutsumi A, Yanagisawa H, Dohmae N, Hattori M, Ichijo H, Yan Z, Kikkawa M, Shirouzu M, Ishitani R, Nureki O.
Nat Struct Mol Biol. doi: 10.1038/s41594-018-0109-6. Epub 2018 Aug 20.

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X.
AAPS J. 2018 Aug 27;20(6):93. doi: 10.1208/s12248-018-0252-3.

Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese Perspective.
Yokoi H, Ho M, Iwamoto S, Suzuki Y, Ansel GM, Azuma N, Handa N, Iida O, Ikeda K, Ikeno F, Ohura N, Rosenfield K, Rundback J, Terashi H, Uchida T, Yokoi Y, Nakamura M, Jaff MR.
Circ J. doi: 10.1253/circj.CJ-18-0014. Epub 2018 Jun 30.

Learning Curve for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System - Initial Analysis of a Japanese Nationwide Registry.
Handa N, Kumamaru H, Torikai K, Kohsaka S, Takayama M, Kobayashi J, Ogawa H, Shirato H, Ishii K, Koike K, Yokoyama Y, Miyata H, Motomura N, Sawa Y; Japanese TAVR Registry Participants.
Circ J. doi: 10.1253/circj.CJ-18-0211. Epub 2018 May 22.

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. doi: 10.1016/j.dmpk.2018.01.005. Epub 2018 Mar 15.

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 Jun;5(2):91-99. doi: 10.1007/s40801-018-0131-3.

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. doi: 10.1253/circj.CJ-17-1425. Epub 2018 Mar 21.

Determining Food Allergens by Skin Sensitization in Mice.
Tamehiro N, Adachi R, Kimura Y, Sakai S, Teshima R, Kondo K.
Curr Protoc Toxicol. doi: 10.1002/cptx.48. Epub 2018 Apr 30.

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 May;109(5):1731-1737. doi: 10.1111/cas.13568.

New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies.
Konishi A, Isobe S, Sato D.
J Vasc Interv Radiol. doi: 10.1016/j.jvir.2017.12.022. Epub 2018 Mar 13.

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. doi: 10.1124/dmd.117.078972. Epub 2018 Feb 23.

Freeze-dried equine-derived redback spider antivenom: a local irritation study by intramuscular injection in rabbits and a repeated-dose toxicity study in rats.
Yamamoto A, Harano S, Shinya N, Nagano A, Miyatsu Y, Sawabe K, Matsumura T, Ato M, Takahashi M, Taki H, Hifumi T.
J Toxicol Pathol. doi: 10.1293/tox.2017-0053. Epub 2018 Feb 19.

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; Working Group for Guidelines on Development of Cell-Based Products for the Treatment of Cerebral Infarction.
Stroke. doi: 10.1161/STROKEAHA.117.019216. Epub 2018 Mar 16.

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. doi: 10.7883/yoken.JJID.2017.291. Epub 2018 Feb 28.

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. doi: 10.1016/j.jpsychires.2017.12.019. Epub 2018 Jan 3.

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 Feb;67(2):637-644.e30. doi: 10.1016/j.jvs.2017.07.141.

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 Feb;60(2):108-114. doi: 10.1111/ped.13495.

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. doi: 10.1253/circj.CJ-17-1156. Epub 2018 Jan 23.

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 Jan 6;5(1):3. doi: 10.3390/medicines5010003.

2017

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. doi: 10.1177/2168479017720248. Epub 2017 Jul 21.

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; following participants of the WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products.
Biologicals. doi: 10.1016/j.biologicals.2017.12.002. Epub 2017 Dec 27.

Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan.
Asano K, Uyama Y, Tohkin M.
Clin Transl Sci. doi: 10.1111/cts.12520. Epub 2017 Nov 15.

Current Japanese Regulatory Systems for Generics and Biosimilars.
Kuribayashi R, Sawanobori K.
J Pharm Sci. doi: 10.1016/j.xphs.2017.10.040. Epub 2017 Nov 4.

Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.
Murakami M, Suzuki Y, Tominaga T.
Circ J. doi: 10.1253/circj.CJ-17-0533. Epub 2017 Sep 7.

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. 2017 Dec 6;9(2):1641-1655. doi: 10.18632/oncotarget.22895.

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. doi: 10.1016/j.toxicon.2017.12.043. Epub 2017 Dec 12.

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. doi: 10.1016/j.yrtph.2017.09.003. Epub 2017 Sep 6.

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. doi: 10.7883/yoken.JJID.2017.125. Epub 2017 Oct 31.

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 Nov 2;7(1):14942. doi: 10.1038/s41598-017-14466-x.

Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.
Ishiguro C, Misu T, Iwasa E, Izawa T.
Pharmacoepidemiol Drug Saf. doi: 10.1002/pds.4252. Epub 2017 Jul 19.

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. doi: 10.1111/cts.12485. Epub 2017 Jul 4.

Angiogenesis, Cancer, and Vascular Aging.
Moriya J, Minamino T.
Front Cardiovasc Med. 2017 Oct 24;4:65. doi: 10.3389/fcvm.2017.00065.

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 Oct 23;7(1):13847. doi: 10.1038/s41598-017-14185-3.

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-MACS investigators.
J Heart Lung Transplant. doi: 10.1016/j.healun.2017.08.002. Epub 2017 Aug 12.

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; IBCD-Faculty.
Eur J Cancer. doi: 10.1016/j.ejca.2017.07.028. Epub 2017 Sep 4.

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.
Kuribayashi R, Appleton S.
Drugs R D. 2017 Sep;17(3):371-379. doi: 10.1007/s40268-017-0186-8.

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. doi: 10.1016/j.ahj.2017.05.003. Epub 2017 May 18.

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. doi: 10.1002/pds.4218. Epub 2017 Jun 14.

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 Jul 24;70(4):423-429. doi: 10.7883/yoken.JJID.2016.360. Epub 2017 Feb 28.

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 Jul 16;6(3):333-338. doi: 10.5455/jice.20170713091550.

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. doi: 10.1177/2168479017696271. Epub 2017 Mar 7.

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. doi: 10.1002/psp4.12203. Epub 2017 Jun 1.

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 Jun 15;7(1):3605. doi: 10.1038/s41598-017-03785-8.

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 Jun 1;38(21):1632-1637. doi: 10.1093/eurheartj/ehx086.

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. doi: 10.1016/j.yrtph.2017.03.008. Epub 2017 Mar 10.

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 Mar;56(3):225-233. doi: 10.1007/s40262-016-0438-8.

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; International Inflammatory Bowel Disease (i-IBD) Working Group.
J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):368-372. doi: 10.1097/MPG.0000000000001284.

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. doi: 10.1080/10543406.2017.1293082. Epub 2017 Mar 21.

2016

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. doi: 10.1002/cpt.537. Epub 2016 Dec 7.

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. doi: 10.1177/2168479016679865. Epub 2016 Dec 29.

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. doi: 10.1177/2168479016680259. Epub 2016 Dec 18.

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. doi: 10.1177/2168479016662682. Epub 2016 Sep 27.

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. doi: 10.1016/j.ahj.2016.07.011. Epub 2016 Aug 3.

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. doi: 10.1177/2168479016648731. Epub 2016 Jul 10.

Effect of design specifications in dose-finding trials for combination therapies in oncology.
Hirakawa A, Sato H, Gosho M.
Pharm Stat. doi: 10.1002/pst.1770. Epub 2016 Aug 19.

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. doi: 10.1002/sim.6981. Epub 2016 May 11.

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. doi: 10.1016/j.ejmech.2016.05.031. Epub 2016 May 18.

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. doi: 10.1016/j.biologicals.2016.06.002. Epub 2016 Jul 22.

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. doi: 10.1016/j.diabet.2016.02.005. Epub 2016 Mar 29.

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 Aug 16;4:e2331. doi: 10.7717/peerj.2331.

Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.
Kuribayashi R, Takishita T, Mikami K.
J Pharm Sci. doi: 10.1016/j.xphs.2016.05.026. Epub 2016 Jun 30.

Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future.
de Bruijn W, Ibáñez C, Frisk P, Bak Pedersen H, Alkan A, Vella Bonanno P, Brkičić LS, Bucsics A, Dedet G, Eriksen J, Fadare JO, Fürst J, Gallego G, Godói IP, Guerra Júnior AA, Gürsöz H, Jan S, Jones J, Joppi R, Kerman S, Laius O, Madzikwa N, Magnússon E, Maticic M, Markovic-Pekovic V, Massele A, Ogunleye O, O'Leary A, Piessnegger J, Sermet C, Simoens S, Tiroyakgosi C, Truter I, Thyberg M, Tomekova K, Wladysiuk M, Vandoros S, Vural EH, Zara C, Godman B.
Front Pharmacol. 2016 Jul 22;7:197. doi: 10.3389/fphar.2016.00197.

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. doi: 10.1002/pds.4032. Epub 2016 May 25.

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. doi: 10.1002/cpt.346. Epub 2016 Mar 31.

Response to Nature's editorial regarding the Japanese legal system for regenerative medicines.
Sato D, Arakawa Y, Isobe S.
Regen Ther. 2016 Jun 2;4:103-104. doi: 10.1016/j.reth.2016.04.003.

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 May 31;4:78-81. doi: 10.1016/j.reth.2016.04.001.

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 Jun;4(6):419-27. doi: 10.1016/j.jchf.2016.01.013.

Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians.
Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Yimin C, Kaneko M, Saito Y, Takeuchi M, Watanabe H, Yamazoe Y, Uyama Y, Kawai S.
Br J Clin Pharmacol. doi: 10.1111/bcp.12884. Epub 2016 Mar 14.

First Approval of Regenerative Medical Products under the PMD Act in Japan.
Konishi A, Sakushima K, Isobe S, Sato D.
Cell Stem Cell. 2016 Apr 7;18(4):434-5. doi: 10.1016/j.stem.2016.03.011.

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 Apr-Jun;19(2):290-301. doi: 10.18433/jpps.v19i2.27066.

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; HBC study group.
Medicine (Baltimore). 2016 Apr;95(14):e3219. doi: 10.1097/MD.0000000000003219.

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 Mar 8;4:e1753. doi: 10.7717/peerj.1753.

Authors' Reply.
Hirakawa A, Sato H.
Stat Med. 2016 Feb 10;35(3):479-80. doi: 10.1002/sim.6751.

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

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

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; National Hospital Organization Network Study Group for Abdominal Aortic Aneurysm in Japan.
Ann Vasc Dis. doi: 10.3400/avd.oa.15-00125. Epub 2016 Jun 2.

2015

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; lymphoma committee of the Japanese Pediatric Leukemia/lymphoma Study Group.
Leuk Lymphoma. doi: 10.3109/10428194.2015.1106534. Epub 2015 Dec 23.

Receptor tyrosine kinase KIT: Prognostic and therapeutic involvement in canine mast cell tumours.
Takeuchi Y, Bonkobara M.
Vet J. doi: 10.1016/j.tvjl.2015.07.012. Epub 2015 Jul 29.

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. doi: 10.1002/cpt.203. Epub 2015 Sep 11.

How should ethnicity-related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States.
Tanaka A, Asano K, Uyama Y.
Clin Pharmacol Ther. doi: 10.1002/cpt.197. Epub 2015 Sep 5.

A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.
Hirakawa A, Wages NA, Sato H, Matsui S.
Stat Med. doi: 10.1002/sim.6533. Epub 2015 May 13.

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. doi: 10.1016/j.biologicals.2015.07.009. Epub 2015 Aug 24.

Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.
Kuribayashi R, Matsuhama M, Mikami K.
AAPS J. doi: 10.1208/s12248-015-9777-x. Epub 2015 May 6.

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

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. doi: 10.1016/j.jconrel.2015.05.259. Epub 2015 May 13.

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. doi: 10.1158/1078-0432.CCR-15-0156. Epub 2015 Apr 10.

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

Systemic antimycotic and antifungal use in eastern Europe: a cross-national database study in coordination with the WHO Regional Office for Europe.
Adriaenssens N, Uka V, Versporten A, Bolokhovets G, Ghazaryan L, Abilova V, Pyshnik G, Spasojevic T, Korinteli I, Kambaralieva B, Cizmovic L, Carp A, Radonjic V, Maqsudova N, Alkan A, Coenen S, Pedersen HB, Sautenkova N, Goossens H; WHO/Europe-ESAC Project Group.
J Antimicrob Chemother. doi: 10.1093/jac/dkv064. Epub 2015 Mar 22.

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 Jun 24;7(2):81-94. doi: 10.1080/19466315.2015.1006373.

Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.
Okada K, Koike K, Sawa Y.
Regen Ther. 2015 May 15;1:80-83. doi: 10.1016/j.reth.2015.04.001.

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

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 Apr;29(2):107-9. doi: 10.1007/s10557-015-6579-4.

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 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036.

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 Mar;49(2):249-253. doi: 10.1177/2168479014551646.

Japanese regulatory authority's perspective on biosimilars.
Nagai S, Yanagihara R, Kishioka Y.
Lancet Oncol. 2015 Mar;16(3):e101. doi: 10.1016/S1470-2045(14)71220-3.

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. doi: 10.1007/978-3-319-18618-4_8.

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 Jan;94(1):e386. doi: 10.1097/MD.0000000000000386.

2014

Regulation of traditional herbal medicinal products in Japan.
Maegawa H, Nakamura T, Saito K.
J Ethnopharmacol. doi: 10.1016/j.jep.2014.07.012. Epub 2014 Jul 17.

Relationship between drug lag and factors associated with clinical trials in Japan.
Ohwaki K, Nakabayashi T.
J Clin Pharm Ther. doi: 10.1111/jcpt.12202. Epub 2014 Sep 8.

New Governmental Regulatory System for Stem Cell-Based Therapies in Japan.
Hara A, Sato D, Sahara Y.
Ther Innov Regul Sci. 2014 Nov;48(6):681-688. doi: 10.1177/2168479014526877.

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. doi: 10.1002/pst.1630. Epub 2014 Jul 16.

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. doi: 10.1016/j.yrtph.2014.06.029. Epub 2014 Jul 17.

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 Sep;48(5):644-650. doi: 10.1177/2168479014524582.

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. doi: 10.1016/j.ajem.2014.06.008. Epub 2014 Jun 12.

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. doi: 10.1200/JCO.2014.55.2208. Epub 2014 Jun 30.

Tatsuya Kondo.
Kondo T, Mullard A.
Nat Rev Drug Discov. 2014 Jul;13(7):490. doi: 10.1038/nrd4376.

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.
Godman B, Malmström RE, Diogene E, Jayathissa S, McTaggart S, Cars T, Alvarez-Madrazo S, Baumgärtel C, Brzezinska A, Bucsics A, Campbell S, Eriksson I, Finlayson A, Fürst J, Garuoliene K, Gutiérrez-Ibarluzea I, Hviding K, Herholz H, Joppi R, Kalaba M, Laius O, Malinowska K, Pedersen HB, Markovic-Pekovic V, Piessnegger J, Selke G, Sermet C, Spillane S, Tomek D, Vončina L, Vlahović-Palčevski V, Wale J, Wladysiuk M, van Woerkom M, Zara C, Gustafsson LL.
Front Pharmacol. 2014 Jun 10;5:109. doi: 10.3389/fphar.2014.00109.

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; International Inflammatory Bowel Disease Working Group.
J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):684-8. doi: 10.1097/MPG.0000000000000322.

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; International Inflammatory Bowel Disease Working Group.
J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):679-83. doi: 10.1097/MPG.0000000000000306.

Comparison of statistical analysis plans in randomize-all phase III trials with a predictive biomarker.
Matsui S, Choai Y, Nonaka T.
Clin Cancer Res. doi: 10.1158/1078-0432.CCR-13-2698. Epub 2014 Apr 1.

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 May;18(5):520-3. doi: 10.1007/s12603-014-0031-5.

Antibiotic use in eastern Europe: a cross-national database study in coordination with the WHO Regional Office for Europe.
Versporten A, Bolokhovets G, Ghazaryan L, Abilova V, Pyshnik G, Spasojevic T, Korinteli I, Raka L, Kambaralieva B, Cizmovic L, Carp A, Radonjic V, Maqsudova N, Celik HD, Payerl-Pal M, Pedersen HB, Sautenkova N, Goossens H; WHO/Europe-ESAC Project Group.
Lancet Infect Dis. doi: 10.1016/S1473-3099(14)70071-4. Epub 2014 Mar 20.

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. doi: 10.1038/nrneph.2014.36. Epub 2014 Mar 18.

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. doi: 10.1016/j.ejmech.2014.02.044. Epub 2014 Feb 18.

Multiregional medical device development: regulatory perspective.
Tamura A, Kutsumi H.
Clin J Gastroenterol. doi: 10.1007/s12328-014-0478-2. Epub 2014 Apr 3.

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 Jan 8;9(1):e84998. doi: 10.1371/journal.pone.0084998.

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

2013

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. doi: 10.1038/clpt.2013.223. Epub 2013 Nov 8.

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 Aug;94(2):195-8. doi: 10.1038/clpt.2013.106.

Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011.
Anahara R.
Ther Innov Regul Sci. 2013 Jul;47(4):424-429. doi: 10.1177/2168479013489302.

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. doi: 10.1038/jhg.2013.36. Epub 2013 May 9.

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. doi: 10.1038/clpt.2012.268. Epub 2013 Jan 15.

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 Jan;47(1):19-22. doi: 10.1177/2168479012469950.

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

2012

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

International vision and strategy for drug regulatory authority: the PMDA's international vision.
Tominaga T, Ando Y, Kondo T.
Clin Pharmacol Ther. doi: 10.1038/clpt.2012.90. Epub 2012 Aug 8.

2011

An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials.
Hirakawa A.
Stat Med. doi: 10.1002/sim.4425. Epub 2011 Nov 23.

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. doi: 10.2133/dmpk.dmpk-11-rv-082. Epub 2011 Dec 27.

Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan.
Arato T, Yamaguchi T.
Biologicals. doi: 10.1016/j.biologicals.2011.08.006. Epub 2011 Sep 13.

Quality, safety and efficacy of follow-on biologics in Japan.
Yamaguchi T, Arato T.
Biologicals. doi: 10.1016/j.biologicals.2011.06.015. Epub 2011 Sep 3.

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

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. doi: 10.1016/j.provac.2011.10.002. Epub 2011 Dec 23.

2010

Adaptive clinical trials for new drug applications in Japan.
Ando Y, Hirakawa A, Uyama Y.
Eur Neuropsychopharmacol. doi: 10.1016/j.euroneuro.2010.09.002. Epub 2010 Oct 18.

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

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. doi: 10.1093/annonc/mdq070. Epub 2010 Mar 23.

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

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. doi: 10.1038/clpt.2009.285. Epub 2010 Jan 27.

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

2008

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

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 Apr;16(4):726-733. doi: 10.1038/mt.2008.19.

cs://pubmed.ncbi.nlm.nih.gov/19351997/" target="_blank">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.

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 Jun 15;109(12):2541-6. doi: 10.1002/cncr.22721.

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 Aug;78(2):102-13. doi: 10.1016/j.clpt.2005.04.001.

Family bias by proxy.
Ikeda M.
Lancet. 2005 Jan 8-14;365(9454):187. doi: 10.1016/S0140-6736(05)17710-1.