Abstract #300883

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JSM 2003 Abstract #300883
Activity Number: 30
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #300883
Title: Use of a Group Sequential Method for Bioequivalence Testing
Author(s): Huaixiang Li*+ and Yi Tsong
Companies: Food and Drug Administration and Food and Drug Administration
Address: CDER, 5600 Fishers Lane, Rockville, MD, 20857-0001,
Keywords: antifungal ; bioequivalence testing ; adaptive group sequential
Abstract:

In designing a parallel group bioequivalence study for topical antifungal products, one problem that the experimenter faces is that a patient is qualified for the study depending on the results of their baseline culture. It can take almost as much time as the length of the study to have the laboratory results. It is not unusual to find that as many as 50% of patients who received treatment are disqualified during or at the completion of the study. We examined the potential applications of a group sequential method with the number of analyses and information times unfixed. Some of the issues relative to the type I error rate inflation will also be discussed.

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