Clinical Equivalence—A Clarification-Reference-Cited by-同舟云学术

Clinical Equivalence—A Clarification

Published:1999-10 Issue:4 Volume:33 Page:1189-1194
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Chuang-Stein Christy

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/10.1177/009286159903300422.pdf

Reference9 articles.

1. Temple RJ. When are clinical trials of a given agent vs placebo no longer appropriate or feasible? Control Clin Trials. 1997;18:613–620.

2. Brody BA. When are placebo-controlled trials no longer appropriate? Control Clin Trials. 1997;18:602–612.

3. Federal Register. International Conference on Har-monisation; Guidance on Statistical Principles for Clinical Trials. 1998;63(No. 179), Wednesday, September 16:49583–49598.

4. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharma-cokin Biopharmaceut. 1987:15(6):657–680.

5. Westlake WJ. Response to bioequivalence testing-A need to rethink. Biometrics. 1981;37:589–594.

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