JSM 2004 - Toronto

Abstract #301349

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Activity Number: 438
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301349
Title: A Comparative Study of Statistical Methods for Population Bioequivalence in 2x2 Cross-over Design
Author(s): Sang-Gue Park*+ and Wan-Youn Yang
Companies: Chung-Ang University and Kyungwon University
Address: Dept. of Statistics, Seoul, International, 156-756, Korea
Keywords: bioequivalence ; cross-over design ; population bioequivalence ; prescribability
Abstract:

The Food and Drug Administration (FDA) issued a second-draft guidance in August 1999 on the subject of in-vivo bioequivalence, which is based on the concepts of individual and population bioequivalence. The intention of this guidance is to replace the 1992 guidance that requires that in-vivo bioequivalence be demonstrated by average bioequivalence. The test for population bioequivalence in the latest FDA guidance document on statistical considerations for bioequivalence studies has been known as very conservative. The FDA test is compared with three tests--Lee, Shao, and Chow (2002), Chow, Shao, and Wang (2003), McNally, Iyer, and Mathew (2002)--for assessing population bioequivalence in 2x2 cross-over design through simulation study.

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