Statistical power for AUC and Cmax

From: Yu_Dale Subject: [NMusers] Statistical power for AUC and Cmax Date:Mon, 24 Jun 2002 11:25:56 -0700 This is not a strictly NONMEM question but may be someone could give me some input here. In designing a bioequivalence study, the traditional approach is to power the study based on Cmax since it is typically more variable than AUC. The idea is that if Cmax passess the BE criterion, AUC will always follow. Is anyone aware of any simulation or publication that verifies this postulate? On the other hand, is the idea of picking one of the two metrics incorrect? Should one treat AUC and Cmax as two separate outcomes and therefore one should consider the joint probability of coming up with 80% power? Thanks for your help in advance. Dale Yu