Literature DB >> 17365227

An alternative approach to assess exchangeability of a test treatment and the standard treatment with normally distributed response.

Yi Tsong1, Meiyu Shen.   

Abstract

In order to assess the equivalence of two treatments, clinical trials are designed to test against the null hypothesis that the difference (or ratio) of two means (proportions) is either smaller than a pre-specified lower equivalence limit or larger than a pre-specified upper equivalence limit. For example, in generic drug evaluation, such approach is defined as average bioequivalence. However, average equivalence type test is often criticized as lack of the ability to assess the exchangeability of the two treatments. In this article, we restate the statistical hypotheses in the form of stochastic inequalities. The stochastic statement can then be generalized to define the probability of exchangeability (i.e., coverage percentage) of the two treatments. The approach will be illustrated with a numeric example.

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Year:  2007        PMID: 17365227     DOI: 10.1080/10543400601177301

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN: 1054-3406            Impact factor:   1.051


  2 in total

1.  Assessing individual equivalence in parallel group and crossover designs: Exact test and sample size procedures.

Authors:  Gwowen Shieh
Journal:  PLoS One       Date:  2022-05-27       Impact factor: 3.752

2.  Responsiveness and minimal clinically important differences after cholecystectomy: GIQLI versus SF-36.

Authors:  Hon-Yi Shi; Hao-Hsien Lee; Chong-Chi Chiu; Herng-Chia Chiu; Yih-Huei Uen; King-Teh Lee
Journal:  J Gastrointest Surg       Date:  2008-05-03       Impact factor: 3.452

  2 in total

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