Abstract #300947

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JSM 2002 Abstract #300947
Activity Number: 185
Type: Contributed
Date/Time: Tuesday, August 13, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #300947
Title: Statistical Test for Population Bioequivalence
Author(s): Yonghee Lee*+
Affiliation(s): StatPlus, Inc.
Address: 1790 Lardley-Langhorne Rd., Yardley, Pennsylvania, 19067, U.S.A
Keywords: Bioequivalence ; population bioequivalence ; confidence limit
Abstract:

FDA (2001) recommends a statistical test for population bioequivalence (PBE) based on the modified large sample method. However, the independence among estimators of variance components, which is the main assumption for the modified large sample method, is not satisfied so that the asymptotic size of FDA test is not equal to the nominal level. In this paper, we will extend the modified large sample method when estimators of variance components are dependent and propose a test which gives the correct asymptotic size. From a simulation study, the proposed test for PBE by using the extension of the modified large sample method shows the better performance than the test recommended by FDA (2001).

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