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Original Articles

Probabilities and sample sizes for the two one-sided tests procedure

Pages 1953-1961 | Received 01 Oct 1992, Published online: 23 Dec 2010
 

Abstract

The two one-sided tests procedure of Schuirmann (1987) has become the standard technique for assessing bioequivalence of two formulations of the same drug. The power of this procedure is examined to determine the sample size required to control the power. A simple approximation to the required sample size is presented.

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