Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

Author:

Kuo Wen-Hua

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Reference14 articles.

1. Anderson C, Cone M, Walker S. Bridging studies in Asia and the impact of the ICH E5 guideline. Drug Inf J. 2003;37(November):107S–116S.

2. Denker AE, et al. Sources of potential ethnic differences in pharmacokinetics. Drug Inf J. 2003;37(November):99S–106S.

3. Kuo WH. Understanding race at the frontier of pharmaceutical regulation: an analysis of the racial difference debate at the ICH. J Law Med Ethics. 2008;36(3):498–505.

4. Question 26 and its answer in the Ministry of Health. Labor, and Wealth’s guidance on the E5 guideline. In Yakugyoziho. ed. Kawarusinyak-ukaihatu no kokusaisenryuku: ICH E5 gaidnrain no inpakuta [Changing global strategies for new drug development: the impact of the ICH E5 guideline]. Tokyo: Yakugyozihosha.

5. Mori K. Recent situation of clinical trial consultation in Japan—especially consultation about bridging study. Presentation at the 2001 APEC Meeting for Pharmaceutical Regulatory Network. Taipei, Taiwan, May 25–26.

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