Basing the Analysis of Comparative Bioavailability Trials on an Individualized Statistical Definition of Equivalence
作者:
S. Wellek,
期刊:
Biometrical Journal
(WILEY Available online 1993)
卷期:
Volume 35,
issue 1
页码: 47-55
ISSN:0323-3847
年代: 1993
DOI:10.1002/bimj.4710350105
出版商: WILEY‐VCH Verlag
关键词: Bioequivalence;Modified sign test;Standardized normal mean;Uniformly most powerful invariant test
数据来源: WILEY
摘要:
AbstractThe conventional definition of bioequivalence in terms of population means only, is criticized for lacking relevance to the individual subject. Both approaches to bioequivalence assessment proposed here for avoiding this shortcoming, focus on the probability of an event induced by the response of a randomly selected subject to two formulations of a given active agent. The first approach leads to converting the basic idea underlying the well‐known 75‐rule into an exact statistical procedure. The second approach is of a parametric nature. It reduces bioequivalence assessment to testing against the alternative hypothesis that the standardized expected value of a Gaussian distribution is contained in a short interval around zero. For this problem, an exact optimal solution is provided as w
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