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Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and clarify the current drug lag. The new drug and the drug lag were defi...

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Detalles Bibliográficos
Autores principales: Tanaka, Mototsugu, Idei, Mayumi, Sakaguchi, Hiroshi, Kato, Ryosuke, Sato, Daisuke, Sawanobori, Kenji, Kawarasaki, Shuichi, Hata, Toshiyuki, Yoshizaki, Asako, Nakamura, Miki, Ikuma, Mutsuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246743/
https://www.ncbi.nlm.nih.gov/pubmed/33048367
http://dx.doi.org/10.1002/cpt.2080