Assessment of the Extrapolation of Foreign Clinical Data for Registration Purposes-Reference-Cited by-同舟云学术

Assessment of the Extrapolation of Foreign Clinical Data for Registration Purposes

Published:2002-07 Issue:3 Volume:36 Page:513-516
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Lin Yeong-Liang,Chiou Yi Jin,Hsiao Chia-Ling,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/10.1177/009286150203600306.pdf

Reference3 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: ICH; 1998.

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

3. Hsiao ML. The current status of clinical trials and GCP in Taiwan. Drug InfJ. 1998;32:1203S–1207S.

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4. Taiwan’s Experience with the Assessment of the Acceptability of the Extrapolation of Foreign Clinical Data for Registration Purposes;Drug Information Journal;2003-04