Lag Time for New Innovative, First-in-Class, Drug Approval in Japan-Reference-Cited by-同舟云学术

Lag Time for New Innovative, First-in-Class, Drug Approval in Japan

Published:2022-04-01 Issue:4 Volume:45 Page:477-482
ISSN:0918-6158
Container-title:Biological and Pharmaceutical Bulletin
language:en
Short-container-title:Biological & Pharmaceutical Bulletin

Author:

Miyazaki Takayuki¹,Komiyama Michiyuki¹,Matsumaru Naoki¹,Maeda Hideki²,Tsukamoto Katsura¹

Affiliation:

1. Global Regulatory Science, Gifu Pharmaceutical University

2. Department of Regulatory Science, Division of Clinical Pharmacy, Meiji Pharmaceutical University

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology,General Medicine

Link

https://www.jstage.jst.go.jp/article/bpb/45/4/45_b21-00898/_pdf

Reference20 articles.

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2. 2) Shenoy P. Multi-regional clinical trials and global drug development. Perspect. Clin. Res., 7, 62–67 (2016).

3. 3) PMDA. “Estimation of drug lag.”: ‹https://www.pmda.go.jp/files/000238010.pdf›, accessed 19 March, 2021.

4. 4) Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, Kawarasaki S, Hata T, Yoshizaki A, Nakamura M, Ikuma M. Evolving landscape of new drug approval in Japan and lags from international birth dates: retrospective regulatory analysis. Clin. Pharmacol. Ther., 109, 1265–1273 (2021).

5. 5) Aronson JK, Green AR. Me-too pharmaceutical products: history, definitions, examples, and relevance to drug shortages and essential medicines lists. Br. J. Clin. Pharmacol., 86, 2114–2122 (2020).

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