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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.


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Table of Contents



2021
Orphan drug designation and development in Japan: 25 years of experience and assessment.
Sakushima K, Takeda H, Aoi Y.
Nat Rev Drug Discov. 2021 Mar 15. doi: 10.1038/d41573-021-00045-3. Online ahead of print.
PMID: 33723413

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. 2021 May 16. doi: 10.1002/cpt.2275. Online ahead of print.
PMID: 33993499

Guidelines for clinical evaluation of anti-cancer drugs.
Minami H, Kiyota N, Kimbara S, Ando Y, Shimokata T, Ohtsu A, Fuse N, Kuboki Y, Shimizu T, Yamamoto N, Nishio K, Kawakami Y, Nihira SI, Sase K, Nonaka T, Takahashi H, Komori Y, Kiyohara K.
Cancer Sci. 2021 May 15. doi: 10.1111/cas.14967. Online ahead of print.
PMID: 33990993

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.
PMID: 33965083

Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma.
Kanno H, Nagata H, Ishiguro A, Tsuzuranuki S, Nakano S, Nonaka T, Kiyohara K, Kimura T, Sugawara A, Okazaki Y, Takae S, Nakabayashi T, Arai H, Suzuki H.
Oncologist. 2021 Apr 29. doi: 10.1002/onco.13805. Online ahead of print.
PMID: 33928712

Nested Case-Control Study Utilizing MID-NET® on Thrombocytopenia Associated With Pegfilgrastim in Patients Treated With Antineoplastic Agents.
Kajiyama K, Ishiguro C, Ando T, Kubota Y, Kinoshita N, Oniyama Y, Iguchi T, Uyama Y.
Clin Pharmacol Ther. 2021 Apr 18. doi: 10.1002/cpt.2263. Online ahead of print.
PMID: 33866559

Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic.
Chong SSF, Kim M, Limoli M, Obscherning E, Wu P, Feisee L, Nakashima N, Lim JCW.
Ther Innov Regul Sci. 2021 Apr 11:1-13. doi: 10.1007/s43441-021-00285-w. Online ahead of print.
PMID: 33840083

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.
Wakao R, Lönnstedt IM, Aoki Y, Chandler RE.
Drug Saf. 2021 Apr 10. doi: 10.1007/s40264-021-01063-1. Online ahead of print.
PMID: 33837924

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.
PMID: 33706800

Achievements and challenges of the Sakigake designation system in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. 2021 Mar 10. doi: 10.1111/bcp.14807. Online ahead of print.
PMID: 33694268

Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Br J Clin Pharmacol. 2021 Jan 28. doi: 10.1111/bcp.14749. Online ahead of print.
PMID: 33511674

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.
PMID: 33738348

Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals.
Hirabayashi Y, Maki K, Kinoshita K, Nakazawa T, Obika S, Naota M, Watanabe K, Suzuki M, Arato T, Fujisaka A, Fueki O, Ito K, Onodera H.
Nucleic Acid Ther. 2021 Apr;31(2):114-125. doi: 10.1089/nat.2020.0879. Epub 2021 Jan 19.
PMID: 33470890

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies.
Wang SV, Pinheiro S, Hua W, Arlett P, Uyama Y, Berlin JA, Bartels DB, Kahler KH, Bessette LG, Schneeweiss S.
BMJ. 2021 Jan 12;372:m4856. doi: 10.1136/bmj.m4856.
PMID: 33436424

Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan.
Sawada S, Ando T, Hirano M, Komiyama N, Iguchi T, Oniyama Y, Ishiguro C, Uyama Y.
Ther Innov Regul Sci. 2021 May;55(3):539-544. doi: 10.1007/s43441-020-00247-8. Epub 2021 Jan 3.
PMID: 33393016

Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data.
Sai K, Nakatani E, Iwama Y, Hiraoka S, Tohkin M, Uyama Y, Saito Y.
Ther Innov Regul Sci. 2021 May;55(3):523-538. doi: 10.1007/s43441-020-00246-9. Epub 2021 Jan 3.
PMID: 33393013


2020
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. 2020 Dec 31. doi: 10.1111/cts.12965. Online ahead of print.
PMID: 33382914

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. 2020 Dec 30:S1879-4068(20)30534-8. doi: 10.1016/j.jgo.2020.12.012. Online ahead of print.
PMID: 33388281

Reliance: a smarter way of regulating medical products - The IPRP survey.
Doerr P, Valentin M, Nakashima N, Orphanos N, Santos G, Balkamos G, Saint-Raymond A.
Expert Rev Clin Pharmacol. 2021 Feb;14(2):173-177. doi: 10.1080/17512433.2021.1865798. Epub 2020 Dec 23.
PMID: 33355025

Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan.
Asano K, Aoi Y, Kamada S, Uyama Y, Tohkin M.
Clin Pharmacol Ther. 2021 Jun;109(6):1555-1563. doi: 10.1002/cpt.2121. Epub 2020 Dec 16.
PMID: 33245786

Control strategy and methods for continuous direct compression processes.
Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, Mano E, Motoyama K, Koide T, Matsui Y, Kurasaki K, Takayama I, Hikage S, Katori N, Kikuchi M, Sakai H, Matsuda Y.
Asian J Pharm Sci. 2021 Mar;16(2):253-262. doi: 10.1016/j.ajps.2020.11.005. Epub 2020 Dec 8.
PMID: 33995618

Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing.
Ishimoto H, Kano M, Sugiyama H, Takeuchi H, Terada K, Aoyama A, Shoda T, Demizu Y, Shimamura J, Yokoyama R, Miyamoto Y, Hasegawa K, Serizawa M, Unosawa K, Osaki K, Asai N, Matsuda Y.
Chem Pharm Bull (Tokyo). 2021 Feb 1;69(2):211-217. doi: 10.1248/cpb.c20-00824. Epub 2020 Dec 8.
PMID: 33298636

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.
PMID: 32930951

Modernization and Strengthening of Bioequivalence Guidelines in Japan.
Kuribayashi R, Yamaguchi T, Takagi K.
Clin Pharmacokinet. 2021 Feb;60(2):145-151. doi: 10.1007/s40262-020-00965-0. Epub 2020 Nov 28.
PMID: 33247363

Regulatory challenges with biosimilars: an update from 20 countries.
Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, Chua HM, Dalili D, Foo F, Gao K, Habahbeh S, Hamel H, Kim GH, Perez Rodriguez V, Putri DE, Rodgers J, Savkina M, Semeniuk O, Srivastava S, Tavares Neto J, Wadhwa M, Yamaguchi T.
Ann N Y Acad Sci. 2021 May;1491(1):42-59. doi: 10.1111/nyas.14522. Epub 2020 Nov 21.
PMID: 33222245

Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass in adult patients undergoing cardiac surgery.
Asada M, Nagata M, Mizuno T, Uchida T, Takahashi H, Makita K, Arai H, Kijima S, Echizen H, Yasuhara M.
Eur J Clin Pharmacol. 2021 May;77(5):735-745. doi: 10.1007/s00228-020-03045-1. Epub 2020 Nov 19.
PMID: 33211137

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M.
Clin Pharmacol Ther. 2021 May;109(5):1265-1273. doi: 10.1002/cpt.2080. Epub 2020 Nov 15.
PMID: 33048367

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A.
J Pharm Sci. 2021 Feb;110(2):594-609. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3.
PMID: 33152375

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.
PMID: 33109554

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.
PMID: 32617874

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.
PMID: 33110091

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States.
Takahashi S, Iwasaki K, Shirato H, Ho M, Umezu M.
J Artif Organs. 2021 Mar;24(1):90-101. doi: 10.1007/s10047-020-01216-6. Epub 2020 Oct 20.
PMID: 33079285

The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness.
Cocoros NM, Arlett P, Dreyer NA, Ishiguro C, Iyasu S, Sturkenboom M, Zhou W, Toh S.
Clin Pharmacol Ther. 2021 May;109(5):1189-1196. doi: 10.1002/cpt.2045. Epub 2020 Oct 8.
PMID: 32911562

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.
PMID: 32725324

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.
PMID: 32613551

Balancing Safety and Efficacy With Early Availability in the Regulation of Regenerative Medicine Product.
Fujiwara Y, Maruyama Y, Honda F.
Clin Pharmacol Ther. 2021 May;109(5):1182-1185. doi: 10.1002/cpt.2034. Epub 2020 Sep 26.
PMID: 32979224

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.
PMID: 32943165

Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan.
Bun S, Yonemori K, Sunadoi H, Nishigaki R, Noguchi E, Okusaka T, Nishida T, Fujiwara Y.
JCO Oncol Pract. 2021 Mar;17(3):e416-e425. doi: 10.1200/OP.20.00131. Epub 2020 Sep 21.
PMID: 32956004

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan.
Yamaguchi T, Uchida E, Okada T, Ozawa K, Onodera M, Kume A, Shimada T, Takahashi S, Tani K, Nasu Y, Mashimo T, Mizuguchi H, Mitani K, Maki K.
Hum Gene Ther. 2020 Oct;31(19-20):1043-1053. doi: 10.1089/hum.2020.156. Epub 2020 Sep 17.
PMID: 32731837

Letter by Kizawa et al Regarding Article, "Aromatase Inhibitors and the Risk of Cardiovascular Outcomes in Women With Breast Cancer: A Population-Based Cohort Study".
Kizawa R, Hara T, Miura Y.
Circulation. 2020 Sep 15;142(11):e154-e155. doi: 10.1161/CIRCULATIONAHA.120.047232. Epub 2020 Sep 14.
PMID: 32924570

Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan.
Takamura K, Tachibana K, Kihira T, Nakai K, Tsutsumi Y, Kondoh M.
Ther Innov Regul Sci. 2021 Mar;55(2):304-308. doi: 10.1007/s43441-020-00215-2. Epub 2020 Sep 11.
PMID: 32918260

Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan.
Kijima S, Ochiai Y, Ishiguro A.
CPT Pharmacometrics Syst Pharmacol. 2020 Oct;9(10):550-552. doi: 10.1002/psp4.12554. Epub 2020 Sep 11.
PMID: 32914930

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.
PMID: 32719865

Role of Roxadustat for ESA-Resistant Renal Anemia? -Read with Caution.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. 2020 Nov;31(11):2737. doi: 10.1681/ASN.2020060821. Epub 2020 Sep 4.
PMID: 32897870

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.
Shimokawa M, Sato D, Wakao R, Arai H.
Clin Pharmacol Ther. 2021 Feb;109(2):295-298. doi: 10.1002/cpt.1986. Epub 2020 Aug 18.
PMID: 33469964

A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations.
Asano J, Hirakawa A.
Pharm Stat. 2020 Nov;19(6):975-1000. doi: 10.1002/pst.2049. Epub 2020 Aug 10.
PMID: 32779393

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint.
Mitsutake Y, Konishi A, Shiba T, Ito T, Ho M, Shirato H.
Heart Vessels. 2021 Feb;36(2):155-162. doi: 10.1007/s00380-020-01676-z. Epub 2020 Aug 10.
PMID: 32776235

Optimization of the quality by design approach for gene therapy products: A case study for adeno-associated viral vectors.
Tanaka T, Hanaoka H, Sakurai S.
Eur J Pharm Biopharm. 2020 Oct;155:88-102. doi: 10.1016/j.ejpb.2020.08.002. Epub 2020 Aug 9.
PMID: 32784043

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.
PMID: 32727913

Report of the use of patient-derived xenograft models in the development of anticancer drugs in Japan.
Tsumura R, Koga Y, Hamada A, Kuwata T, Sasaki H, Doi T, Aikawa K, Ohashi A, Katano I, Ikarashi Y, Ito M, Ochiai A.
Cancer Sci. 2020 Sep;111(9):3386-3394. doi: 10.1111/cas.14564. Epub 2020 Jul 28.
PMID: 32639672

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System.
Mitsutake Y, Konishi A, Handa N, Ho M, Shirato H, Ito T, Koike K, Mochizuki S, Ishii K.
Circ J. 2020 Aug 25;84(9):1568-1574. doi: 10.1253/circj.CJ-20-0133. Epub 2020 Jul 17.
PMID: 32684539

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.
PMID: 32630328

Strategic Outlook toward 2030: Japan's research for allergy and immunology - Secondary publication.
Adachi T, Kainuma K, Asano K, Amagai M, Arai H, Ishii KJ, Ito K, Uchio E, Ebisawa M, Okano M, Kabashima K, Kondo K, Konno S, Saeki H, Sonobe M, Nagao M, Hizawa N, Fukushima A, Fujieda S, Matsumoto K, Morita H, Yamamoto K, Yoshimoto A, Tamari M.
Allergol Int. 2020 Oct;69(4):561-570. doi: 10.1016/j.alit.2020.04.006. Epub 2020 Jun 27.
PMID: 32600925

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group.
BMJ. 2020 Jun 17;369:m115. doi: 10.1136/bmj.m115.
PMID: 32554564

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group.
Trials. 2020 Jun 17;21(1):528. doi: 10.1186/s13063-020-04334-x.
PMID: 32546273

Achieving Regulatory Alignment for Anti-Infective Clinical Trials.
Nambiar S, Cavaleri M, Sato J.
ACS Infect Dis. 2020 Jun 12;6(6):1308-1310. doi: 10.1021/acsinfecdis.0c00270.
PMID: 32529834

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. 2020 Jul;111(7):2460-2471. doi: 10.1111/cas.14449. Epub 2020 Jun 12.
PMID: 32402135

Characteristics on Drug Safety Measures in Japan Stratified by System Organ Classes and Therapeutic Categories in Relation to the Approval Date.
Hiramatsu A, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2020 Nov;54(6):1534-1540. doi: 10.1007/s43441-020-00180-w. Epub 2020 Jun 10.
PMID: 32524501

'All In': a pragmatic framework for COVID-19 testing and action on a global scale.
Pettit SD, Jerome KR, Rouquié D, Mari B, Barbry P, Kanda Y, Matsumoto M, Hester S, Wehmas L, Botten JW, Bruce EA.
EMBO Mol Med. 2020 Jun 8;12(6):e12634. doi: 10.15252/emmm.202012634. Epub 2020 May 27.
PMID: 32375201

Toward global standardization of conducting fair investigations of allegations of research misconduct.
Nouchi R, Aihara H, Arie F, Asashima M, Daida H, Fudano J, Fujiwara Y, Fushiki S, Geller RJ, Hatano K, Homma T, Kimura M, Kuroki T, Miki K, Morita I, Nitta K, Shinohara A, Siomi MC, Yoshida M, Ichikawa I.
Account Res. 2020 Aug;27(6):327-346. doi: 10.1080/08989621.2020.1747019. Epub 2020 May 12.
PMID: 32223327

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. 2020 Apr 24;84(5):786-791. doi: 10.1253/circj.CJ-19-1092. Epub 2020 Apr 1.
PMID: 32238666

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. 2020 May;65:1-9. doi: 10.1016/j.biologicals.2020.02.005. Epub 2020 Mar 27.
PMID: 32224101

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.
Konishi A, Ho M, Mitsutake Y, Ouchi T, Nakamura M, Shirato H.
Intern Med. 2021 Jan 15;60(2):161-166. doi: 10.2169/internalmedicine.4286-19. Epub 2020 Mar 19.
PMID: 32188811

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.
Handa N, Mochizuki S, Fujiwara Y, Shimokawa M, Wakao R, Arai H.
J Artif Organs. 2020 Sep;23(3):203-206. doi: 10.1007/s10047-020-01161-4. Epub 2020 Feb 28.
PMID: 32112156

Validation of a new serum granulocyte-macrophage colony-stimulating factor autoantibody testing kit.
Nakata K, Sugi T, Kuroda K, Yoshizawa K, Takada T, Tazawa R, Ueda T, Aoki A, Abe M, Tatsumi K, Eda R, Kondoh S, Morimoto K, Tanaka T, Yamaguchi E, Takahashi A, Oda M, Ishii H, Izumi S, Sugiyama H, Nakagawa A, Tomii K, Suzuki M, Konno S, Ohkouchi S, Hirano T, Handa T, Hirai T, Inoue Y, Arai T, Asakawa K, Sakagami T, Tanaka T, Mikami A, Kitamura N.
ERJ Open Res. 2020 Jan 27;6(1):00259-2019. doi: 10.1183/23120541.00259-2019. eCollection 2020 Jan.
PMID: 32010720

Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents.
Tohkin M, Saito Y, Yagi S, Asano K, Maekawa K, Osabe M, Iida S, Miyata N.
Drug Metab Pharmacokinet. 2020 Apr;35(2):187-190. doi: 10.1016/j.dmpk.2020.01.003. Epub 2020 Jan 18.
PMID: 32007355

WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T; 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. 2020 May;65:50-59. doi: 10.1016/j.biologicals.2019.12.008. Epub 2020 Jan 17.
PMID: 31959504

Big Data in the Assessment of Pediatric Medication Safety.
McMahon AW, Cooper WO, Brown JS, Carleton B, Doshi-Velez F, Kohane I, Goldman JL, Hoffman MA, Kamaleswaran R, Sakiyama M, Sekine S, Sturkenboom MCJM, Turner MA, Califf RM.
Pediatrics. 2020 Feb;145(2):e20190562. doi: 10.1542/peds.2019-0562. Epub 2020 Jan 14.
PMID: 31937606


2019
Development of a new Japanese guideline on drug interaction for drug development and appropriate provision of information.
Ishiguro A, Sato R, Nagai N.
Drug Metab Pharmacokinet. 2020 Feb;35(1):12-17. doi: 10.1016/j.dmpk.2019.11.009. Epub 2019 Dec 20.
PMID: 31902469

Adverse Drug Reaction Relief System in Japan: From Clinical Perspective.
Watanabe M, Nishikawa H, Miyasaka N, Sato R, Sato D, Hayashi Y, Kondo T.
Ther Innov Regul Sci. 2020 Jul;54(4):731-737. doi: 10.1007/s43441-019-00003-7. Epub 2019 Dec 5.
PMID: 32557292

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.
PMID: 31559542

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.
PMID: 31062276

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. 2020 Apr;219:243-249.e1. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8.
PMID: 31708158

Possible Contribution of Drug Approval Summaries Published by Drug Regulatory Authorities on Scientific Discussion and Drug Development.
Tanese K, Yamori T.
Clin Pharmacol Drug Dev. 2020 Jan;9(1):6-10. doi: 10.1002/cpdd.744. Epub 2019 Oct 14.
PMID: 31608600

Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases.
Yoon C, Nam KC, Lee YK, Kang Y, Choi SJ, Shin HM, Jang H, Kim JK, Kwon BS, Ishikawa H, Woo E.
J Korean Med Sci. 2019 Oct 14;34(39):e255. doi: 10.3346/jkms.2019.34.e255.
PMID: 31602825

Function of Prion Protein and the Family Member, Shadoo.
Onodera T, Nishimura T, Sugiura K, Sakudo A.
Curr Issues Mol Biol. 2020;36:67-88. doi: 10.21775/cimb.036.067. Epub 2019 Sep 27.
PMID: 31559969

Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting.
Konishi A, Mitsutake Y, Ho M, Handa N, Koike K, Mochizuki S, Ishii K.
J Cardiol. 2020 Mar;75(3):255-260. doi: 10.1016/j.jjcc.2019.07.016. Epub 2019 Sep 17.
PMID: 31537439

Evolving Vision of Regulatory Science in the Global Medical Community.
Kondo T, Hayashi Y, Sato J, Sekine S, Hoshino T, Sato D.
Clin Pharmacol Ther. 2020 Jan;107(1):136-139. doi: 10.1002/cpt.1604. Epub 2019 Sep 13.
PMID: 31376148

Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan.
Sakurai A, Ogawa T, Matsumoto J, Kihira T, Fukushima S, Miyata I, Shimizu H, Itamura S, Ouchi K, Hamada A, Tani K, Okabe N, Yamaguchi T.
Vaccine. 2019 Oct 8;37(43):6573-6579. doi: 10.1016/j.vaccine.2019.08.031. Epub 2019 Sep 7.
PMID: 31506194

Establishment of the MID-NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan.
Yamaguchi M, Inomata S, Harada S, Matsuzaki Y, Kawaguchi M, Ujibe M, Kishiba M, Fujimura Y, Kimura M, Murata K, Nakashima N, Nakayama M, Ohe K, Orii T, Sueoka E, Suzuki T, Yokoi H, Takahashi F, Uyama Y.
Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1395-1404. doi: 10.1002/pds.4879. Epub 2019 Aug 29.
PMID: 31464008

The Development of an Electronic Phenotyping Algorithm for Identifying Rhabdomyolysis Patients in the MID-NET Database.
Izukura R, Kandabashi T, Wakata Y, Nojiri C, Nohara Y, Yamashita T, Takada A, Park J, Uyama Y, Nakashima N.
Stud Health Technol Inform. 2019 Aug 21;264:1498-1499. doi: 10.3233/SHTI190503.
PMID: 31438200

ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.
Tanaka M, Shinohara K, Ono A, Ikuma M.
J Am Soc Nephrol. 2019 Sep;30(9):1772. doi: 10.1681/ASN.2019060556. Epub 2019 Aug 16.
PMID: 31420407

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.
PMID: 31116395

Cardiovascular risks associated with dipeptidyl peptidase-4 inhibitors monotherapy compared with other antidiabetes drugs in the Japanese population: A nationwide cohort study.
Komamine M, Kajiyama K, Ishiguro C, Uyama Y.
Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1166-1174. doi: 10.1002/pds.4847. Epub 2019 Jul 23.
PMID: 31338935

Identification of gastrointestinal perforation based on ICD-10 code in a Japanese administrative medical information database and associated drug exposure risk factors.
Tanigawa M, Kataoka Y, Kishino T, Kohama M, Uyama Y, Suzuki Y, Yokoi H.
Pharmacoepidemiol Drug Saf. 2019 Jul;28(7):976-984. doi: 10.1002/pds.4837. Epub 2019 Jun 13.
PMID: 31197887

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC.
Circulation. 2019 Jul 16;140(3):240-261. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22.
PMID: 31116032

Applications of MALDI mass spectrometry imaging for pharmacokinetic studies during drug development.
Nishidate M, Hayashi M, Aikawa H, Tanaka K, Nakada N, Miura SI, Ryu S, Higashi T, Ikarashi Y, Fujiwara Y, Hamada A.
Drug Metab Pharmacokinet. 2019 Aug;34(4):209-216. doi: 10.1016/j.dmpk.2019.04.006. Epub 2019 Apr 24.
PMID: 31101590

Regulatory approval review of transcatheter mitral valve repair - Difference in the indication between the USA and Japan.
Konishi A, Ho M, Ouchi T, Mitsutake Y, Shirato H.
J Cardiol. 2019 Jul;74(1):13-18. doi: 10.1016/j.jjcc.2019.03.013. Epub 2019 Apr 17.
PMID: 31005388

Pediatric drug regulation: International perspectives.
Baum VC, Bax R, Heon D, Yang Z, Sakiyama M.
Paediatr Anaesth. 2019 Jun;29(6):572-582. doi: 10.1111/pan.13638. Epub 2019 Apr 14.
PMID: 30924233

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. 2019 May;28(5):601-608. doi: 10.1002/pds.4777. Epub 2019 Apr 3.
PMID: 30945387

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.
Sai K, Yoshida A, Hanatani T, Imatoh T, Takeuchi M, Narukawa M, Watanabe H, Uyama Y, Saito Y.
Br J Clin Pharmacol. 2019 Jun;85(6):1270-1282. doi: 10.1111/bcp.13893. Epub 2019 Mar 28.
PMID: 30735569

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.
PMID: 30690463

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials.
Nonaka T, Igeta M, Matsui S.
Pharm Stat. 2019 Jul;18(4):459-475. doi: 10.1002/pst.1937. Epub 2019 Mar 5.
PMID: 30838777

Oseltamivir phosphate-Lifting the restriction on its use to treat teenagers with influenza in Japan.
Takeuchi S, Tetsuhashi M, Sato D.
Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):434-436. doi: 10.1002/pds.4721. Epub 2019 Mar 4.
PMID: 30834626

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan.
Takami A, Hirata K, Ishiguro C, Hanaoka H, Uyama Y.
Clin Pharmacol Ther. 2019 Jun;105(6):1471-1476. doi: 10.1002/cpt.1342. Epub 2019 Feb 10.
PMID: 30588617

Promotion of Japan's participation in global clinical trials.
Kondo H, Shimada Y, Ozawa T.
Drug Discov Today. 2019 Apr;24(4):939-942. doi: 10.1016/j.drudis.2019.01.016. Epub 2019 Jan 30.
PMID: 30710642

Optimal follow-up intervals for different stages of chronic kidney disease: a prospective observational study.
Hirano K, Kobayashi D, Kohtani N, Uemura Y, Ohashi Y, Komatsu Y, Yanagita M, Hishida A.
Clin Exp Nephrol. 2019 May;23(5):613-620. doi: 10.1007/s10157-018-01684-4. Epub 2019 Jan 28.
PMID: 30687877

Visit-to-visit variability in estimated glomerular filtration rate predicts hospitalization and death due to cardiovascular events.
Suzuki A, Obi Y, Hayashi T, Kotani N, Uemura Y, Imai E, Makino H, Hishida A.
Clin Exp Nephrol. 2019 May;23(5):661-668. doi: 10.1007/s10157-019-01695-9. Epub 2019 Jan 28.
PMID: 30687876

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.
PMID: 31787657


2018
Global Regulatory Landscape.
Matsuda Y.
AAPS PharmSciTech. 2018 Dec 17;20(1):2. doi: 10.1208/s12249-018-1230-x.
PMID: 30560302

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

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.
PMID: 30006871

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.
PMID: 30442137

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. 2018 Nov 24;82(12):3111. doi: 10.1253/circj.CJ-18-1066. Epub 2018 Oct 30.
PMID: 30381694

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. eCollection 2018 Oct 12.
PMID: 30416685

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.
PMID: 30287851

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.
Watanabe K, Murakami M, Masuyama K, Ishiguro C, Matsuda T.
Pharmacoepidemiol Drug Saf. 2018 Nov;27(11):1265-1276. doi: 10.1002/pds.4662. Epub 2018 Sep 25.
PMID: 30252199

The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts.
Harrison RW, Radhakrishnan V, Allen JC Jr, Lam PS, Allocco DJ, Brar S, Fahy M, Zhang Z, Fisher R, Ikeno F, Généreux P, Kimura T, Liu M, Lye WK, Nagai H, Suzuki Y, White R, Krucoff MW.
Am Heart J. 2018 Dec;206:61-71. doi: 10.1016/j.ahj.2018.08.017. Epub 2018 Sep 7.
PMID: 30342296

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework.
Tsukamoto K, Cnop M, Mori D, Kume S, Anazawa T, Doi M, Chikazawa K, Matsumaru N.
Ther Innov Regul Sci. 2019 Jul;53(4):535-541. doi: 10.1177/2168479018795854. Epub 2018 Sep 3.
PMID: 30176740

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X.
AAPS J. 2018 Aug 27;20(6):93. doi: 10.1208/s12248-018-0252-3.
PMID: 30151612

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. eCollection 2018 Dec.
PMID: 30182068

Cryo-EM structures of the human volume-regulated anion channel LRRC8.
Kasuya G, Nakane T, Yokoyama T, Jia Y, Inoue M, Watanabe K, Nakamura R, Nishizawa T, Kusakizako T, Tsutsumi A, Yanagisawa H, Dohmae N, Hattori M, Ichijo H, Yan Z, Kikkawa M, Shirouzu M, Ishitani R, Nureki O.
Nat Struct Mol Biol. 2018 Sep;25(9):797-804. doi: 10.1038/s41594-018-0109-6. Epub 2018 Aug 20.
PMID: 30127360

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. 2019 Feb;105(2):436-447. doi: 10.1002/cpt.1166. Epub 2018 Aug 20.
PMID: 29951994

Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese Perspective.
Yokoi H, Ho M, Iwamoto S, Suzuki Y, Ansel GM, Azuma N, Handa N, Iida O, Ikeda K, Ikeno F, Ohura N, Rosenfield K, Rundback J, Terashi H, Uchida T, Yokoi Y, Nakamura M, Jaff MR.
Circ J. 2018 Aug 24;82(9):2233-2239. doi: 10.1253/circj.CJ-18-0014. Epub 2018 Jun 30.
PMID: 29962385

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM.
Lancet Haematol. 2018 Nov;5(11):e563-e598. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18.
PMID: 29907552

Critical roles of inflammation in atherosclerosis.
Moriya J.
J Cardiol. 2019 Jan;73(1):22-27. doi: 10.1016/j.jjcc.2018.05.010. Epub 2018 Jun 12.
PMID: 29907363

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.
PMID: 29476420

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. 2018 Jun 25;82(7):1951-1958. doi: 10.1253/circj.CJ-18-0211. Epub 2018 May 22.
PMID: 29794375

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.
Kondo H, Shibatsuji M, Yasuda N.
Ther Innov Regul Sci. 2019 Mar;53(2):193-198. doi: 10.1177/2168479018771312. Epub 2018 May 2.
PMID: 29719977

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.
PMID: 29878624

Determining Food Allergens by Skin Sensitization in Mice.
Tamehiro N, Adachi R, Kimura Y, Sakai S, Teshima R, Kondo K.
Curr Protoc Toxicol. 2018 May;76(1):e48. doi: 10.1002/cptx.48. Epub 2018 Apr 30.
PMID: 30040230

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.
Konishi A, Ho M, Shirai Y, Shirato H.
Circ J. 2018 May 25;82(6):1487-1490. doi: 10.1253/circj.CJ-17-1425. Epub 2018 Mar 21.
PMID: 29563353

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. 2018 Apr;49(4):e145-e152. doi: 10.1161/STROKEAHA.117.019216. Epub 2018 Mar 16.
PMID: 29581346

Points-to-consider documents: Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population.
Hiratsuka M, Hirasawa N, Oshima Y, Kodama S, Miyata T, Dan T, Takatoku H, Kuribayashi H, Nakamura R, Saito Y.
Drug Metab Pharmacokinet. 2018 Jun;33(3):141-149. doi: 10.1016/j.dmpk.2018.01.005. Epub 2018 Mar 15.
PMID: 29703433

New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies.
Konishi A, Isobe S, Sato D.
J Vasc Interv Radiol. 2018 May;29(5):657-660. doi: 10.1016/j.jvir.2017.12.022. Epub 2018 Mar 13.
PMID: 29548874

Venom and Antivenom of the Redback Spider (Latrodectus hasseltii) in Japan. Part I. Venom Extraction, Preparation, and Laboratory Testing.
Matsumura T, Mashiko R, Sato T, Itokawa K, Maekawa Y, Ogawa K, Isawa H, Yamamoto A, Mori S, Horita A, Ginnaga A, Miyatsu Y, Takahashi M, Taki H, Hifumi T, Sawabe K, Ato M.
Jpn J Infect Dis. 2018 Mar 22;71(2):116-121. doi: 10.7883/yoken.JJID.2017.291. Epub 2018 Feb 28.
PMID: 29491237

Physiologically Based Pharmacokinetic Modeling of Bosentan Identifies the Saturable Hepatic Uptake As a Major Contributor to Its Nonlinear Pharmacokinetics.
Sato M, Toshimoto K, Tomaru A, Yoshikado T, Tanaka Y, Hisaka A, Lee W, Sugiyama Y.
Drug Metab Dispos. 2018 May;46(5):740-748. doi: 10.1124/dmd.117.078972. Epub 2018 Feb 23.
PMID: 29475833

Freeze-dried equine-derived redback spider antivenom: a local irritation study by intramuscular injection in rabbits and a repeated-dose
toxicity study in rats.

Yamamoto A, Harano S, Shinya N, Nagano A, Miyatsu Y, Sawabe K, Matsumura T, Ato M, Takahashi M, Taki H, Hifumi T.
J Toxicol Pathol. 2018 Apr;31(2):105-112. doi: 10.1293/tox.2017-0053. Epub 2018 Feb 19.
PMID: 29749999

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.
PMID: 29389426

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.
PMID: 29288517

Registry Assessment of Peripheral Interventional Devices (RAPID) - Registry Assessment of Peripheral Interventional Devices Core Data Elements.
Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein R, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL.
Circ J. 2018 Jan 25;82(2):316-322. doi: 10.1253/circj.CJ-17-1156. Epub 2018 Jan 23.
PMID: 29367497

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.
PMID: 29316611

Impact of demographic factors on the antidepressant effect: A patient-level data analysis from depression trials submitted to the Pharmaceuticals and Medical Devices Agency in Japan.
Nakabayashi T, Hara A, Minami H.
J Psychiatr Res. 2018 Mar;98:116-123. doi: 10.1016/j.jpsychires.2017.12.019. Epub 2018 Jan 3.
PMID: 29334636


2017
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. 2018 Mar;52:83-91. doi: 10.1016/j.biologicals.2017.12.002. Epub 2017 Dec 27.
PMID: 29289489

Combined therapy with gas gangrene antitoxin and recombinant human soluble thrombomodulin for Clostridium perfringens sepsis in a rat model.
Hifumi T, Nakano D, Chiba J, Takahashi M, Yamamoto A, Fujisawa Y, Kawakita K, Kuroda Y, Nishiyama A.
Toxicon. 2018 Jan;141:112-117. doi: 10.1016/j.toxicon.2017.12.043. Epub 2017 Dec 12.
PMID: 29246581

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. eCollection 2018 Jan 5.
PMID: 29416720

Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan.
Asano K, Uyama Y, Tohkin M.
Clin Transl Sci. 2018 Mar;11(2):182-188. doi: 10.1111/cts.12520. Epub 2017 Nov 15.
PMID: 29139198

Current Japanese Regulatory Systems for Generics and Biosimilars.
Kuribayashi R, Sawanobori K.
J Pharm Sci. 2018 Mar;107(3):785-787. doi: 10.1016/j.xphs.2017.10.040. Epub 2017 Nov 4.
PMID: 29113922

Molecular phylogenetic analysis of new Entoloma rhodopolium-related species in Japan and its identification method using PCR-RFLP.
Kondo K, Nakamura K, Ishigaki T, Sakata K, Obitsu S, Noguchi A, Fukuda N, Nagasawa E, Teshima R, Nishimaki-Mogami T.
Sci Rep. 2017 Nov 2;7(1):14942. doi: 10.1038/s41598-017-14466-x.
PMID: 29097736

Venom and Antivenom of the Redback Spider (Latrodectus hasseltii) in Japan. Part II. Experimental Production of Equine Antivenom against the Redback Spider.
Mori S, Horita A, Ginnaga A, Miyatsu Y, Sawabe K, Matsumura T, Ato M, Yamamoto A, Shibayama K, Arai S, Yamagishi T, Takahashi M, Taki H, Hifumi T.
Jpn J Infect Dis. 2017 Nov 22;70(6):635-641. doi: 10.7883/yoken.JJID.2017.125. Epub 2017 Oct 31.
PMID: 29093316

Angiogenesis, Cancer, and Vascular Aging.
Moriya J, Minamino T.
Front Cardiovasc Med. 2017 Oct 24;4:65. doi: 10.3389/fcvm.2017.00065. eCollection 2017.
PMID: 29114540

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.
PMID: 29062064

Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.
Murakami M, Suzuki Y, Tominaga T.
Circ J. 2018 Feb 23;82(3):636-643. doi: 10.1253/circj.CJ-17-0533. Epub 2017 Sep 7.
PMID: 28883226

Investigating toxicity specific to adjuvanted vaccines.
Matsumoto M, Komatsu SI, Ikeda T, Shimomura K, Watanabe K, Hirabayashi K, Sawada JI, Maki K, Shinoda K, Fueki O, Onodera H.
Regul Toxicol Pharmacol. 2017 Dec;91:29-38. doi: 10.1016/j.yrtph.2017.09.003. Epub 2017 Sep 6.
PMID: 28888957

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. 2017 Oct;84:325-334. doi: 10.1016/j.ejca.2017.07.028. Epub 2017 Sep 4.
PMID: 28865260

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.
PMID: 28577294

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. 2017 Oct;36(10):1087-1096. doi: 10.1016/j.healun.2017.08.002. Epub 2017 Aug 12.
PMID: 28942783

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.
Kondo H, Saint-Raymond A, Yasuda N.
Ther Innov Regul Sci. 2018 Mar;52(2):214-219. doi: 10.1177/2168479017720248. Epub 2017 Jul 21.
PMID: 29714521

Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.
Ishiguro C, Misu T, Iwasa E, Izawa T.
Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1314-1320. doi: 10.1002/pds.4252. Epub 2017 Jul 19.
PMID: 28722235

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. eCollection 2017 Jul-Sep.
PMID: 28894633

Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia.
Miyazaki K, Sato Y, Hanaoka H, Uyama Y.
Clin Transl Sci. 2017 Nov;10(6):503-508. doi: 10.1111/cts.12485. Epub 2017 Jul 4.
PMID: 28675655

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.
PMID: 28620243

Comparative study of the number of report and time-to-onset of the reported adverse event between the biosimilars and the originator of filgrastim.
Kobayashi T, Kamada I, Komura J, Toyoshima S, Ishii-Watabe A.
Pharmacoepidemiol Drug Saf. 2017 Aug;26(8):917-924. doi: 10.1002/pds.4218. Epub 2017 Jun 14.
PMID: 28612945

Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective.
Sato M, Ochiai Y, Kijima S, Nagai N, Ando Y, Shikano M, Nomura Y.
CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):413-415. doi: 10.1002/psp4.12203. Epub 2017 Jun 1.
PMID: 28568566

Improving public health by improving clinical trial guidelines and their application.
Landray MJ, Bax JJ, Alliot L, Buyse M, Cohen A, Collins R, Hindricks G, James SK, Lane S, Maggioni AP, Meeker-O'Connell A, Olsson G, Pocock SJ, Rawlins M, Sellors J, Shinagawa K, Sipido KR, Smeeth L, Stephens R, Stewart MW, Stough WG, Sweeney F, Van de Werf F, Woods K, Casadei B.
Eur Heart J. 2017 Jun 1;38(21):1632-1637. doi: 10.1093/eurheartj/ehx086.
PMID: 28329235

Prevention of sudden cardiac death in the young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium.
Idriss SF, Berger S, Harmon KG, Kindman A, Kleiman R, Lopez-Anderson M, Molossi S, Saarel TE, Strnadova C, Todaro T, Shinagawa K, Morrow V, Krucoff M, Vetter V, Wright TJ.
Am Heart J. 2017 Aug;190:123-131. doi: 10.1016/j.ahj.2017.05.003. Epub 2017 May 18.
PMID: 28760206

Non-neoplastic lesions found only in the two-year bioassays but not in shorter toxicity studies of rats.
Nonaka M, Amakasu K, Saegusa Y, Naota M, Nishimura T, Ogawa K, Nishikawa A.
Regul Toxicol Pharmacol. 2017 Jun;86:199-204. doi: 10.1016/j.yrtph.2017.03.008. Epub 2017 Mar 10.
PMID: 28288808

Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council.
Hattori Y, Hanaoka H, Uyama Y.
Ther Innov Regul Sci. 2017 Jul;51(4):426-430. doi: 10.1177/2168479017696271. Epub 2017 Mar 7.
PMID: 30227059

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.
PMID: 27461251

Pediatric Crohn Disease Clinical Outcome Assessments and Biomarkers: Current State and Path Forward for Global Collaboration.
Sun H, Vesely R, Lee KJ, Klein A, Ikima M, Mulberg AE; International Inflammatory Bowel Disease (i-IBD) Working Group.
J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):368-372. doi: 10.1097/MPG.0000000000001284.
PMID: 27253661

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.
PMID: 28250257

Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: Application to breast cancer data.
Asano J, Hirakawa A.
J Biopharm Stat. 2017;27(6):918-932. doi: 10.1080/10543406.2017.1293082. Epub 2017 Mar 21.
PMID: 28324665


2016
Risk of Acute Asthma Attacks Associated With Nonsteroidal Anti-inflammatory Drugs: A Self-Controlled Case Series.
Takeuchi Y, Ando T, Ishiguro C, Uyama Y.
Ther Innov Regul Sci. 2017 May;51(3):332-341. doi: 10.1177/2168479016679865. Epub 2016 Dec 29.
PMID: 30231709

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products.
Kondo H, Sugita T, Ida N, Fukushima H, Yasuda N.
Ther Innov Regul Sci. 2017 May;51(3):355-359. doi: 10.1177/2168479016680259. Epub 2016 Dec 18.
PMID: 30231707

The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.
Tominaga T, Miyazaki S, Oniyama Y, Weber AD, Kondo T.
Clin Pharmacol Ther. 2017 Aug;102(2):277-282. doi: 10.1002/cpt.537. Epub 2016 Dec 7.
PMID: 27737512

The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States.
Kondo H, Hata T, Ito K, Koike H, Kono N.
Ther Innov Regul Sci. 2017 Jan;51(1):51-54. doi: 10.1177/2168479016662682. Epub 2016 Sep 27.
PMID: 30235998

Effect of design specifications in dose-finding trials for combination therapies in oncology.
Hirakawa A, Sato H, Gosho M.
Pharm Stat. 2016 Nov;15(6):531-540. doi: 10.1002/pst.1770. Epub 2016 Aug 19.
PMID: 27539365

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. eCollection 2016.
PMID: 27602295

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.
Harrison RW, Radhakrishnan V, Lam PS, Allocco DJ, Brar S, Fahy M, Fisher R, Ikeno F, Généreux P, Kimura T, Liu M, Lye WK, Mintz GS, Nagai H, Suzuki Y, White R, Allen JC Jr, Krucoff MW.
Am Heart J. 2016 Dec;182:103-110. doi: 10.1016/j.ahj.2016.07.011. Epub 2016 Aug 3.
PMID: 27914489

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. eCollection 2016.
PMID: 27516740

Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S.
Biologicals. 2016 Sep;44(5):467-79. doi: 10.1016/j.biologicals.2016.06.002. Epub 2016 Jul 22.
PMID: 27461129

Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression.
Tanemura N, Uyama Y, Nagashima K, Suzuki T, Asahina Y, Kobayashi Y, Iyo M, Yokote K, Hanaoka H.
Ther Innov Regul Sci. 2016 Nov;50(6):743-750. doi: 10.1177/2168479016648731. Epub 2016 Jul 10.
PMID: 30231732

Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.
Kuribayashi R, Takishita T, Mikami K.
J Pharm Sci. 2016 Aug;105(8):2270-7. doi: 10.1016/j.xphs.2016.05.026. Epub 2016 Jun 30.
PMID: 27372551

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. eCollection 2016 Jun.
PMID: 31245493

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.
PMID: 27256745

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. eCollection 2016 Jun.
PMID: 31245489

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

Synthesis and biological evaluation of novel FK228 analogues as potential isoform selective HDAC inhibitors.
Narita K, Matsuhara K, Itoh J, Akiyama Y, Dan S, Yamori T, Ito A, Yoshida M, Katoh T.
Eur J Med Chem. 2016 Oct 4;121:592-609. doi: 10.1016/j.ejmech.2016.05.031. Epub 2016 May 18.
PMID: 27318982

An adaptive dose-finding method using a change-point model for molecularly targeted agents in phase I trials.
Sato H, Hirakawa A, Hamada C.
Stat Med. 2016 Oct 15;35(23):4093-109. doi: 10.1002/sim.6981. Epub 2016 May 11.
PMID: 27221807

First Approval of Regenerative Medical Products under the PMD Act in Japan.
Konishi A, Sakushima K, Isobe S, Sato D.
Cell Stem Cell. 2016 Apr 7;18(4):434-5. doi: 10.1016/j.stem.2016.03.011.
PMID: 27058934

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.
PMID: 27518176

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.
PMID: 27057853

Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.
Sekine S, Pinnow EE, Wu E, Kurtzig R, Hall M, Dal Pan GJ.
Clin Pharmacol Ther. 2016 Jul;100(1):102-8. doi: 10.1002/cpt.346. Epub 2016 Mar 31.
PMID: 26853718

Glycaemia and autistic traits in very low birth weight infants in adulthood.
Sato R, Shirai K, Maekawa M, Genma R, Ohki S, Morita H, Suda T, Watanabe H.
Diabetes Metab. 2016 Sep;42(4):285-6. doi: 10.1016/j.diabet.2016.02.005. Epub 2016 Mar 29.
PMID: 27037012

Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians.
Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Yimin C, Kaneko M, Saito Y, Takeuchi M, Watanabe H, Yamazoe Y, Uyama Y, Kawai S.
Br J Clin Pharmacol. 2016 Jun;81(6):1078-90. doi: 10.1111/bcp.12884. Epub 2016 Mar 14.
PMID: 26774055

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. eCollection 2016.
PMID: 26989609

Authors' Reply.
Hirakawa A, Sato H.
Stat Med. 2016 Feb 10;35(3):479-80. doi: 10.1002/sim.6751.
PMID: 26757958

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.
PMID: 26919617

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.
PMID: 26849515

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. 2016;9(2):102-7. doi: 10.3400/avd.oa.15-00125. Epub 2016 Jun 2.
PMID: 27375803


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. 2016 Jul;57(7):1657-64. doi: 10.3109/10428194.2015.1106534. Epub 2015 Dec 23.
PMID: 26694130

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.
Pignatti F, Ashby D, Brass EP, Eichler HG, Frey P, Hillege HL, Hori A, Levitan B, Liberti L, Löfstedt RE, McAuslane N, Micaleff A, Noel RA, Postmus D, Renn O, Sabourin BJ, Salmonson T, Walker S.
Clin Pharmacol Ther. 2015 Nov;98(5):522-33. doi: 10.1002/cpt.203. Epub 2015 Sep 11.
PMID: 26261064

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

Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.
Hayakawa T, Aoi T, Bravery C, Hoogendoorn K, Knezevic I, Koga J, Maeda D, Matsuyama A, McBlane J, Morio T, Petricciani J, Rao M, Ridgway A, Sato D, Sato Y, Stacey G, Sakamoto N, Trouvin JH, Umezawa A, Yamato M, Yano K, Yokote H, Yoshimatsu K, Zorzi-Morre P.
Biologicals. 2015 Sep;43(5):283-97. doi: 10.1016/j.biologicals.2015.07.009. Epub 2015 Aug 24.
PMID: 26315651

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.
PMID: 26342202

Receptor tyrosine kinase KIT: Prognostic and therapeutic involvement in canine mast cell tumours.
Takeuchi Y, Bonkobara M.
Vet J. 2016 Apr;210:5-6. doi: 10.1016/j.tvjl.2015.07.012. Epub 2015 Jul 29.
PMID: 26896296

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.
PMID: 26001933

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.
PMID: 26167243

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. eCollection 2015 Jun.
PMID: 31245444

General considerations regarding the in vitro and in vivo properties of block copolymer micelle products and their evaluation.
Sakai-Kato K, Nishiyama N, Kozaki M, Nakanishi T, Matsuda Y, Hirano M, Hanada H, Hisada S, Onodera H, Harashima H, Matsumura Y, Kataoka K, Goda Y, Okuda H, Kawanishi T.
J Control Release. 2015 Jul 28;210:76-83. doi: 10.1016/j.jconrel.2015.05.259. Epub 2015 May 13.
PMID: 25979322

A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.
Hirakawa A, Wages NA, Sato H, Matsui S.
Stat Med. 2015 Oct 30;34(24):3194-213. doi: 10.1002/sim.6533. Epub 2015 May 13.
PMID: 25974405

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

An Antibody-Drug Conjugate Directed against Lymphocyte Antigen 6 Complex, Locus E (LY6E) Provides Robust Tumor Killing in a Wide Range of Solid Tumor Malignancies.
Asundi J, Crocker L, Tremayne J, Chang P, Sakanaka C, Tanguay J, Spencer S, Chalasani S, Luis E, Gascoigne K, Desai R, Raja R, Friedman BA, Haverty PM, Polakis P, Firestein R.
Clin Cancer Res. 2015 Jul 15;21(14):3252-62. doi: 10.1158/1078-0432.CCR-15-0156. Epub 2015 Apr 10.
PMID: 25862760

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.
PMID: 25842974

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

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. 2015 Jul;70(7):2173-5. doi: 10.1093/jac/dkv064. Epub 2015 Mar 22.
PMID: 25802285

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.
PMID: 25744011

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.
PMID: 30222411

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.
PMID: 25752552

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.
PMID: 26374217

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.
PMID: 25569668


2014
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.
PMID: 30227468

Relationship between drug lag and factors associated with clinical trials in Japan.
Ohwaki K, Nakabayashi T.
J Clin Pharm Ther. 2014 Dec;39(6):649-52. doi: 10.1111/jcpt.12202. Epub 2014 Sep 8.
PMID: 25200123

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.
PMID: 30231453

Regulation of traditional herbal medicinal products in Japan.
Maegawa H, Nakamura T, Saito K.
J Ethnopharmacol. 2014 Dec 2;158 Pt B:511-5. doi: 10.1016/j.jep.2014.07.012. Epub 2014 Jul 17.
PMID: 25043783

Considerations for non-clinical safety studies of therapeutic peptide vaccines.
Matsumoto M, Komatsu S, Tsuchimoto M, Matsui H, Watanabe K, Nakamura K, Amakasu K, Ito K, Fueki O, Sawada J, Maki K, Onodera H.
Regul Toxicol Pharmacol. 2014 Oct;70(1):254-60. doi: 10.1016/j.yrtph.2014.06.029. Epub 2014 Jul 17.
PMID: 25042360

Assessing the prediction accuracy of cure in the Cox proportional hazards cure model: an application to breast cancer data.
Asano J, Hirakawa A, Hamada C.
Pharm Stat. 2014 Nov-Dec;13(6):357-63. doi: 10.1002/pst.1630. Epub 2014 Jul 16.
PMID: 25044997

Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.
Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei LJ.
J Clin Oncol. 2014 Aug 1;32(22):2380-5. doi: 10.1200/JCO.2014.55.2208. Epub 2014 Jun 30.
PMID: 24982461

Considerations for tetanus infection in an adult with a protective tetanus antibody level.
Hifumi T, Yamamoto A, Takahashi M, Koido Y, Kawakita K, Kuroda Y.
Am J Emerg Med. 2014 Sep;32(9):1125. doi: 10.1016/j.ajem.2014.06.008. Epub 2014 Jun 12.
PMID: 25027203

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. eCollection 2014.
PMID: 24959145

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.
PMID: 24866782

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

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.
PMID: 24886739

Multiregional medical device development: regulatory perspective.
Tamura A, Kutsumi H.
Clin J Gastroenterol. 2014 Apr;7(2):108-16. doi: 10.1007/s12328-014-0478-2. Epub 2014 Apr 3.
PMID: 26183624

Comparison of statistical analysis plans in randomize-all phase III trials with a predictive biomarker.
Matsui S, Choai Y, Nonaka T.
Clin Cancer Res. 2014 Jun 1;20(11):2820-30. doi: 10.1158/1078-0432.CCR-13-2698. Epub 2014 Apr 1.
PMID: 24691019

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. 2014 May;14(5):381-7. doi: 10.1016/S1473-3099(14)70071-4. Epub 2014 Mar 20.
PMID: 24657114

Drug discovery in renal disease--towards a more efficient framework.
Miyata T, Ando T, Hiragi H, Watanabe K, Yamamoto F, Vaughan DE, Kurokawa T, Oshima Y, van Ypersele de Strihou C, Takeuchi M.
Nat Rev Nephrol. 2014 May;10(5):290-6. doi: 10.1038/nrneph.2014.36. Epub 2014 Mar 18.
PMID: 24642801

Total synthesis of burkholdacs A and B and 5,6,20-tri-epi-burkholdac A: HDAC inhibition and antiproliferative activity.
Fukui Y, Narita K, Dan S, Yamori T, Ito A, Yoshida M, Katoh T.
Eur J Med Chem. 2014 Apr 9;76:301-13. doi: 10.1016/j.ejmech.2014.02.044. Epub 2014 Feb 18.
PMID: 24589486

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.
Kurihara C, Kusuoka H, Ono S, Kakee N, Saito K, Takehara K, Tsujide K, Nabeoka Y, Sakuhiro T, Aoki H, Morishita N, Suzuki C, Kachi S, Kondo E, Komori Y, Isobe T, Kageyama S, Watanabe H.
PLoS One. 2014 Jan 8;9(1):e84998. doi: 10.1371/journal.pone.0084998. eCollection 2014.
PMID: 24416332

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.
PMID: 25033370


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. 2014 May;95(5):533-41. doi: 10.1038/clpt.2013.223. Epub 2013 Nov 8.
PMID: 24213186

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

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.
PMID: 30235526

Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan.
Ishiguro A, Yagi S, Uyama Y.
J Hum Genet. 2013 Jun;58(6):313-6. doi: 10.1038/jhg.2013.36. Epub 2013 May 9.
PMID: 23657427

Balancing societal needs and regulatory certainty: the case study of peramivir in Japan.
Tominaga T, Ando Y, Nagai N, Sato J, Kondo T.
Clin Pharmacol Ther. 2013 Apr;93(4):342-4. doi: 10.1038/clpt.2012.268. Epub 2013 Jan 15.
PMID: 23422872
 
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.
PMID: 30227480

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.
PMID: 23327579


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

International vision and strategy for drug regulatory authority: the PMDA's international vision.
Tominaga T, Ando Y, Kondo T.
Clin Pharmacol Ther. 2012 Sep;92(3):349-51. doi: 10.1038/clpt.2012.90. Epub 2012 Aug 8.
PMID: 22871996


2011
Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels.
Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y.
Drug Metab Pharmacokinet. 2012;27(1):142-9. doi: 10.2133/dmpk.dmpk-11-rv-082. Epub 2011 Dec 27.
PMID: 22201121

An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials.
Hirakawa A.
Stat Med. 2012 Mar 15;31(6):516-32. doi: 10.1002/sim.4425. Epub 2011 Nov 23.
PMID: 22108785

Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan.
Arato T, Yamaguchi T.
Biologicals. 2011 Sep;39(5):289-92. doi: 10.1016/j.biologicals.2011.08.006. Epub 2011 Sep 13.
PMID: 21917473

Quality, safety and efficacy of follow-on biologics in Japan.
Yamaguchi T, Arato T.
Biologicals. 2011 Sep;39(5):328-32. doi: 10.1016/j.biologicals.2011.06.015. Epub 2011 Sep 3.
PMID: 21890377
 
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.
PMID: 21691273

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions.
McFarland R, Verthelyi D, Casey W, Arciniega J, Isbrucker R, Schmitt M, Finn T, Descamps J, Horiuchi Y, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D.
Procedia Vaccinol. 2011;5:16-32. doi: 10.1016/j.provac.2011.10.002. Epub 2011 Dec 23.
PMID: 32288913


2010
Adaptive clinical trials for new drug applications in Japan.
Ando Y, Hirakawa A, Uyama Y.
Eur Neuropsychopharmacol. 2011 Feb;21(2):175-9. doi: 10.1016/j.euroneuro.2010.09.002. Epub 2010 Oct 18.
PMID: 20961739

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

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

Participation of elderly patients in registration trials for oncology drug applications in Japan.
Yonemori K, Hirakawa A, Komiyama N, Kouno T, Ando M, Fujiwara Y, Urano T, Akagawa H, Maruyama H, Toyoshima S.
Ann Oncol. 2010 Oct;21(10):2112-2118. doi: 10.1093/annonc/mdq070. Epub 2010 Mar 23.
PMID: 20332138

Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.
Ichimaru K, Toyoshima S, Uyama Y.
Clin Pharmacol Ther. 2010 Mar;87(3):362-6. doi: 10.1038/clpt.2009.285. Epub 2010 Jan 27.
PMID: 20107436

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.
PMID: 20208385


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.
PMID: 24410553

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. Epub 2016 Dec 8.
PMID: 28178464

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


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.
PMID: 17477381


2005
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.
PMID: 16084844

Family bias by proxy.
Ikeda M.
Lancet. 2005 Jan 8-14;365(9454):187. doi: 10.1016/S0140-6736(05)17710-1.
PMID: 15639302

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