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

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Title: Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
Authors: Tanaka M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Idei M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Sakaguchi H; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Kato R; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Sato D; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Sawanobori K; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Kawarasaki S; Office of New Drug 2, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Hata T; Office of New Drug 3, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Yoshizaki A; Office of New Drug 4, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nakamura M; Office of New Drug 5, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Ikuma M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 May; Vol. 109 (5), pp. 1265-1273. Date of Electronic Publication: 2020 Nov 15.
Publication Type: Journal Article
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
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  Data: <searchLink fieldCode="AU" term="%22Tanaka+M%22">Tanaka M</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Idei+M%22">Idei M</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Sakaguchi+H%22">Sakaguchi H</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Kato+R%22">Kato R</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Sato+D%22">Sato D</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Sawanobori+K%22">Sawanobori K</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Kawarasaki+S%22">Kawarasaki S</searchLink>; Office of New Drug 2, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Hata+T%22">Hata T</searchLink>; Office of New Drug 3, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Yoshizaki+A%22">Yoshizaki A</searchLink>; Office of New Drug 4, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Nakamura+M%22">Nakamura M</searchLink>; Office of New Drug 5, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Ikuma+M%22">Ikuma M</searchLink>; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
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        Value: 10.1002/cpt.2080
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      – TitleFull: Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
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              Text: 2021 May
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