Bioequivalence and Bioavailability Forum • Refuse-to-Receive Standards

Refuse-to-Receive Standards [Design Issues]

posted by M.tareq – 2017-03-17 14:11 (3037 d 09:18 ago) – Posting: # 17161
Views: 6,433

sorry for the late reply

Thanks Dan and Helmut

question about unexpected high variability in fast state, and sample size estimation based on published assessment reports other BE studies
read in your lectures about pooling of CV, however the validity of sample size estimation based on these studies, what if we ended up with higher CV than expected, would be allowable to go with a 2nd stage, after power evaluation ?

thanks in advance

Complete thread:

Fed VS Fast state in BE studies M.tareq 2017-02-26 09:34 [Design Issues]
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
  - PPIs sometimes highly variable even in fasted state Helmut 2017-02-27 11:32
    - PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
      - Refuse-to-Receive Standards Helmut 2017-02-27 16:25
        
        Refuse-to-Receive StandardsM.tareq 2017-03-17 13:11
        Refuse-to-Receive Standards nobody 2017-03-17 16:27