栗林亮佑 (Ryosuke Kuribayashi) - マイポータル

基本情報

所属: 医薬品医療機器総合機構課長

学位: 薬科学(2017年富山大学)

J-GLOBAL ID: 202101018952257889
researchmap会員ID: R000032069

研究キーワード

レギュラトリーサイエンス

委員歴

2025年4月 - 2026年9月

WHO Biosimilar WG Expert
2022年9月 - 2026年9月

AMED, 次世代治療・診断実現のための創薬基盤技術開発事業（腸内マイクロバイオーム制御による次世代創薬技術の開発）, 科学技術調査員
2017年10月 - 2024年3月

厚生労働省, 後発医薬品等の同等性試験ガイドライン検討委員会構成員

受賞

2026年9月

RSセンター長賞
2025年7月

RSセンター長賞
2024年7月

RSセンター長賞

論文

Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines

Hiroyuki Yoshida, Yasuhiro Abe, Miho Kasuga, Kohei Makino, Ryosuke Kuribayashi, Kazunori Takagi, Tokio Morita, Yukihiro Goda, Yoji Sato

Therapeutic Innovation & Regulatory Science 60(4) 965-971 2026年3月25日査読有り
Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.

Ai Fukaya-Shiba, Akiko Ogata, Ryosuke Kuribayashi, Akira Sakurai, Kanako Suzuki, Shunsuke Takadama, Jihei Nishimura, Jumpei Uchiyama, Hiroki Ohge, Takamasa Takeuchi …

Frontiers in pharmacology 16 1713471-1713471 2025年12月査読有り
A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.

Alfredo García-Arieta, Andrew Tam, Florencia Tiseyra, Eduardo Agostinho Freitas Fernandes, Kelen Carine Costa Soares, Raphael Sanches Pereira, Henrike Potthast, Katalina Mettke, Ya-Wen Chang, Li-Feng Hsu …

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques 28 14721-14721 2025年11月査読有り
Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments.

Kanoko Goto, Aya Hariu, Ryosuke Kuribayashi

Pharmaceutical medicine 2025年9月19日査読有り最終著者責任著者
18

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference

B. Schug, G. Beuerle, E. Bilensoy, J. Cook, E. Fernandes, S. Haertter, R. Kuribayashi, M. Mehta, P. Paixao, A. Seidlitz …

European Journal of Pharmaceutical Sciences 212 107129-107129 2025年9月査読有り
Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU.

Aya Hariu, Yuka Saino, Ryosuke Kuribayashi

Naunyn-Schmiedeberg's archives of pharmacology 399(1) 1481-1496 2025年8月13日査読有り筆頭著者最終著者責任著者
Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan

Miho Kasuga, Kimika Kuwana, Ryosuke Kuribayashi

European Journal of Drug Metabolism and Pharmacokinetics 50(4) 353-361 2025年6月9日査読有り筆頭著者最終著者責任著者
The 100th Monoclonal Antibody Product is Approved in Japan.

Aya Hariu, Yukiko Shirahata, Kayo Shinohara, Ryosuke Kuribayashi

The AAPS journal 27(4) 105-105 2025年6月4日査読有り筆頭著者最終著者責任著者
Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information

Ryosuke Kuribayashi, Aya Hariu, Yuka Saino, Kayo Shinohara

Naunyn-Schmiedeberg's Archives of Pharmacology 398(7) 9357-9365 2025年2月14日査読有り筆頭著者責任著者
Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.

Ryosuke Kuribayashi, Kanoko Goto, Takumi Ogawa

The AAPS journal 26(6) 113-113 2024年11月12日査読有り筆頭著者責任著者
Two decades of new drug approvals in Japan

Ryosuke Kuribayashi, Aya Hariu, Yasuhiro Kishioka, Akira Sakurai

Nature Reviews Drug Discovery 24(1) 12-13 2024年10月2日査読有り筆頭著者責任著者
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan

Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka

Expert Opinion on Biological Therapy 24(7) 637-645 2024年7月2日査読有り筆頭著者責任著者
Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments

Ryosuke Kuribayashi, Aya Hariu, Ayuki Nakano, Yasuhiro Kishioka

Pharmaceutical Medicine 38(3) 225-239 2024年4月29日査読有り筆頭著者責任著者
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

Eduardo Agostinho Freitas Fernandes, Joy van Oudtshoorn, Andrew Tam, Liliana Carolina Arévalo González, Erwin Guzmán Aurela, Henrike Potthast, Katalina Mettke, Ryosuke Kuribayashi, Kohei Shimojo, Miho Kasuga …

Journal of Pharmacy & Pharmaceutical Sciences 27 2024年3月21日査読有り
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.

Ryosuke Kuribayashi, Ayuki Nakano, Aya Hariu, Yasuhiro Kishioka, Futaba Honda

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 37(4) 443-451 2023年5月25日査読有り筆頭著者責任著者
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme

Andrew Tam, Alfredo Garcia-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodriguez Martinez, Milly Divinsky, Rami Kariv, Henrike Potthast, April C. Braddy …

Journal of Pharmacy & Pharmaceutical Sciences 25 323-339 2022年10月8日査読有り
First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA

Ryosuke Kuribayashi, Miho Kasuga, Kimika Kuwana, Toru Yamaguchi

Therapeutic Innovation & Regulatory Science 57(2) 173-177 2022年9月13日査読有り筆頭著者責任著者
Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future.

Miho Kasuga, Ryosuke Kuribayashi, Takumi Ogawa, Akiko Ugi, Toru Yamaguchi, Kazunori Takagi, Mitsue Hirota

European journal of drug metabolism and pharmacokinetics 46(6) 711-719 2021年11月査読有り筆頭著者責任著者
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

Matthias Shona Roost, Henrike Potthast, Chantal Walther, Alfredo García-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodríguez Martínez, Andrew Tam, Clare Rodrigues …

Journal of Pharmacy & Pharmaceutical Sciences 24 548-562 2021年10月25日査読有り
Modernization and Strengthening of Bioequivalence Guidelines in Japan.

Ryosuke Kuribayashi, Toru Yamaguchi, Kazunori Takagi

Clinical pharmacokinetics 60(2) 145-151 2021年2月査読有り筆頭著者責任著者