Determination of equivalence of two drugs in clinical trial

Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2002, Vol. 7 ›› Issue (6): 559-561.

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Determination of equivalence of two drugs in clinical trial

ZHENG Qing-Shan, SUN Rui-Yuan, CHEN Zhi-Yang¹

Anhui Provincial Center for Drug Clinical Evaluation &Yijishan Hospital,Wannan Medical College,Wuhu 241001;
¹ Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030

Received:2002-09-30 Revised:2002-10-15 Online:2002-12-26 Published:2020-11-20

Abstract

Abstract: The best method is the bioequivalence test in order to determine whether two drugs give rise to the same or similar efficacy,and it should be the basis of procedures for estimating the sample size needed to detect an equivalence.The power of test can not conclude an equivalence at p>0.05 even in a larger sample size.

Key words: clinical trial, biometry, power, bioequivalence test, two one-side t test, probability

CLC Number:

ZHENG Qing-Shan, SUN Rui-Yuan, CHEN Zhi-Yang. Determination of equivalence of two drugs in clinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2002, 7(6): 559-561.

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Determination of equivalence of two drugs in clinical trial

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