AUC passes with 0.05 and Cmax with 0.0294 [Two-Stage / GS Designs]

posted by Mikalai  – Belarus, 2019-09-18 16:56 (398 d 13:51 ago) – Posting: # 20611
Views: 4,192

Dear Helmut,

» 1. If interim power is <80%, your assumptions about the CV were not correct. Assess the study with the adjusted α 0.0294.
»    a. If you pass, stop.

What prevents us from evaluating the bioequivalence at α-level of 5% as the first step, and if we pass the bioequivalence criteria, we stop the trial. If we fail, we then evaluate the power. If power is more than 80% for the failed parameter, we stop the trial and we are done. If power is less than 80% for the failed parameter, then we go the next stage and adust α-level correspondingly to preserve overall α-level at 0,5. Of course, this should be written in the protocol and is a deviation, maybe a big one, from Potvin C method.

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