Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences
被引:0
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作者:
Wen-Hua Kuo
论文数: 0引用数: 0
h-index: 0
机构:National Yang-Ming University,Center for Humanities and Social Science and Institute of Public Health
Wen-Hua Kuo
机构:
[1] National Yang-Ming University,Center for Humanities and Social Science and Institute of Public Health
来源:
Drug information journal : DIJ / Drug Information Association
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2009年
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43卷
/
1期
关键词:
ICH;
E5 guideline;
Bridging study;
Global drug development;
D O I:
暂无
中图分类号:
学科分类号:
摘要:
In the past 10 years since the implementation of the E5 guideline, bridging studies have been one of the most controversial ICH concepts for East Asian states. This article reveals the dynamics of bridging studies by comprehensively reviewing their evolution and policy impacts in Japan and Taiwan from a comparative perspective.
机构:
Tokyo Teishin Hosp, Org Pharmaceut Safety & Res, Chiyoda Ku, Tokyo 1028798, JapanTokyo Teishin Hosp, Org Pharmaceut Safety & Res, Chiyoda Ku, Tokyo 1028798, Japan