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Abstract Details

Activity Number: 343
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306310
Title: Group Sequential Method for PK Bioequivalence Crossover Studies
Author(s): Huaixiang Li*+ and Stella Grosser
Address: 20913 Severndale Terrace, Germanton, MD, 20876, United States
Keywords: PK Bioequivalence test ; interim analysis ; geometric mean ratio ; coefficient of variation

Bioequivalence of two drug products is usually assessed using a single-stage cross-over study and analyzing the pharmacokinetic parameters AUCt, AUCinf, and Cmax of the products. A two-stage, group-sequential cross-over study design, measuring these same parameters, has been proposed instead. Our simulation shows that the power for the two-stage design is generally lower than the power for the regular one-stage design; this discrepancy increases with increasing within-patient coefficient of variation (CV).

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