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Activity Number: 179
Type: Contributed
Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308186
Title: Assessment of Exchangeability in Equivalence Trial
Author(s): Yi Tsong*+ and Xiaoyu Dong and Meiyu Shen
Companies: FDA and FDA and FDA
Keywords: equivalence ; exchangeability ; Probability-based ; Parameter-based ; tolerance interval ; two one-sided test
Abstract:

The objective of exchangeability assessment is to demonstrate that if a patient taking the test treatment will have the equivalent effect if switching to the reference treatment and vice versa. The convcntional individual bioequivalence test combines the differences in mean and variance into one test statistic. The approach has been shown lacking of the properties of average equivalence. An exchangeability test based on tolerance interval or probability-based exchangeability was proposed to address the problem. The tolerance interval based approach may be used in the form of two-sided test and two one-sided tests. The two-sided test approach leads to an approximate test and the two one-sided tests approach leads to the issues of multiple comparisons. The exact power function of the two-sided test approach is difficult to derive, the sample size determination needs to be done with a simulation-oriented approach. The power function of each of the two one-side tolerance interval tests is exact, but the multiple comparisons lead to the complication of the sample size determination. The exact and/or approximation of the sample size/power functions of the approaches iare discussed.


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