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

posted by Mikalai  – Belarus, 2019-09-18 16:56  – Posting: # 20611
Views: 1,488

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.
Regards,
Mikalai

Complete thread:

Activity
 Admin contact
20,138 posts in 4,246 threads, 1,387 registered users;
online 36 (0 registered, 36 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 15:46 CET

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5