Probability of Success in BE studies [Design Issues]

posted by Achievwin – US, 2024-05-03 15:43 (423 d 19:04 ago) – Posting: # 23977
Views: 4,553

Recently I was asked to give Probability of success for a proposed BE study, My thinking is Target study power (usually 80%) is POS with additional correction factor due to the variability during study conduct applied to this target power, is my understanding correct?

Challenge is that do you substract or a multiply the variability factor?

e.g. POS = Target Power (90) - 30 (CV)= 60 0r 90X(1-0.30)=63%

Achievwin

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,680 registered users;
104 visitors (0 registered, 104 guests [including 39 identified bots]).
Forum time: 10:47 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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