Bioequivalence and Bioavailability Forum • Probability of Success in BE studies

Probability of Success in BE studies [Design Issues]

posted by Achievwin – US, 2024-05-03 15:43 (773 d 14:25 ago) – Posting: # 23977
Views: 7,305

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:

Probability of Success in BE studiesAchievwin 2024-05-03 13:43
- Probability of Success in BE studies Helmut 2024-05-03 14:15
  - Probability of Success in BE studies Achievwin 2024-05-06 14:49
    - Probability of Success in BE studies d_labes 2024-05-06 15:16
      - Probability of Success in BE studies Achievwin 2024-05-06 15:31
    - Assumptions (plural) Helmut 2024-05-06 15:31
      - Assumptions (plural) Achievwin 2024-05-06 15:51