Author:
Lin Yeong-Liang,Wu Chien-Hua,Chan K. Arnold
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)
Reference18 articles.
1. Naito C. Necessity and requirements of bridging studies and their present status in Japan. Int J Clin Pharmacol Ther. 2000;38:80–86.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1CH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5). Geneva, Switzerland: International Conference on Harmonisation; 1996.
3. Lin YL, Chiou YJ, Hsiao CL, et al. Assessment of extrapolation of foreign clinical data as a basis for registration purposes. Drug Inf J. 2002;36: 513–556.
4. Lin YL, Chern HD, Chu ML. Taiwan’s experience with the assessment of the acceptability of the extrapolation of foreign clinical data for registration purposes. Drug Inf J. 2003;37:143–145.
5. Guideline for good epidemiology practices for drugs, device and vaccine research in the United States, International Society for Pharmacoepidemiology 1996. Available at: http://www.pharmacoepi.org/resources/goodprac.htm. Accessed September 13, 2004.
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