Hybrid B/C [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2019-09-18 17:09  – Posting: # 20612
Views: 3,484

Dear Mikalai,

» 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.

That’s more or less a hybrid of Method C (where you asses power first) and Method B (where you assess power after). You are free to develop such a method but have to validate it (i.e., find a suitable adjusted α which controls the type I error in every possible combination of n1/CV).

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,798 posts in 4,354 threads, 1,445 registered users;
online 15 (0 registered, 15 guests [including 5 identified bots]).
Forum time: 23:58 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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