PMDA initiatives to enhance drug development via multi-regional clinical trials.
作者信息
Otsubo Yasuto
机构信息
Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Tokyo 100-0013, Japan.
出版信息
Transl Clin Pharmacol. 2024 Dec;32(4):173-176. doi: 10.12793/tcp.2024.32.e16. Epub 2024 Nov 29.
Abstract
摘要
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本文引用的文献
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Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.评估日本和美国在药物研发启动、新药申请和批准方面的滞后情况，以及局部与多区域临床试验的影响。
Pharmaceut Med. 2021 Jul;35(4):253-260. doi: 10.1007/s40290-021-00393-w. Epub 2021 Jul 22.
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Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.日本新药审批格局的演变及其与国际上市日期的差距：回顾性监管分析。
Clin Pharmacol Ther. 2021 May;109(5):1265-1273. doi: 10.1002/cpt.2080. Epub 2020 Nov 15.
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