Probability of Success in BE studies [Design Issues]

posted by Achievwin – US, 2024-05-03 15:43 (46 d 02:39 ago) – Posting: # 23977
Views: 1,468

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%


Complete thread:

UA Flag
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
106 visitors (0 registered, 106 guests [including 8 identified bots]).
Forum time: 18:22 CEST (Europe/Vienna)

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

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