Taiwan’s Experience with the Assessment of the Acceptability of the Extrapolation of Foreign Clinical Data for Registration Purposes-Reference-Cited by-同舟云学术

Taiwan’s Experience with the Assessment of the Acceptability of the Extrapolation of Foreign Clinical Data for Registration Purposes

Published:2003-04 Issue:2 Volume:37 Page:143-145
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Lin Yeong-Liang,Chern Herng-Der,Chu Mong-Ling

Publisher

Springer Science and Business Media LLC

Subject

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

Link

http://link.springer.com/content/pdf/10.1177/009286150303700202.pdf

Reference4 articles.

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5). Geneva, Switzerland: International Conference on Harmonisation; 1996.

2. Naito C. Necessity and requirements of bridging studies and their present status in Japan. Int J Clin Phammcol Ther. 2000;38:80–86.

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: 513–516.

4. Hawkey CJ. The gastroenterologist’s caseload: Contribution of the rheumatologist. Semin Arthritis Rheum, 1997;26:11–15.

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