, Volume 12, Issue 1, pp 83-91

A new statistical procedure for testing equivalence in two-group comparative bioavailability trials

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Abstract

The clinical problem of testing for equivalence in comparative bioavailability trials is restated in terms of the proper statistical hypotheses. A simple t-test procedure for these hypotheses has been devloped that is more powerful than the methods based on usual (shortest) and symmetric confidence intervals. In this note, this new procedure is explained and an example is given, including the method for sample size determination.

Preparation of this manuscript was supported in part by Grant #CA15145 from the National Cancer Institute.