343 – Selected Analysis and Bioequivalence
Group Sequential Method for PK Bioequivalence Crossover Studies
Stella Grosser
FDA/CDER
Huaixiang Li
FDA/OTS/CDER/OB/DBG
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).