Abstract #301134


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JSM 2002 Abstract #301134
Activity Number: 92
Type: Topic Contributed
Date/Time: Monday, August 12, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301134
Title: A More Powerful Average Bioequivalence Analysis for the 2x2 Crossover
Author(s): Devan Mehrotra*+ and Catalina Stefanescu
Affiliation(s): Merck Research Laboratories and Cornell University
Address: 785 Jolly Rd, Bldg C, Blue Bell, Pennsylvania, 19422, USA
Keywords: ANCOVA ; Bootstrap ; Biased estimator
Abstract:

Power/sample size calculations for 2x2 crossover studies to establish average bioequivalence are usually done under the belief that the true (geometric) means of the test and control treatments are identical. If we really believe that the true means are identical, then standard analyses are arguably inefficient, because they fail to capitalize on our prior belief. On the other hand, even small departures from the identical means assumption could make the actual power to show bioequivalence notably smaller than the planned power. We propose an innovative analytic approach that resolves these problematic issues. Our approach uses simple tools from the areas of covariate adjustment and bootstrapping. Simulation results and a numerical example are used to illustrate the improved power and utility of the proposed new methodology.


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