Bioequivalence and Bioavailability Forum • Different power of AUC vs. Cmax at stage I

Different power of AUC vs. Cmax at stage I - continuation rules [Two-Stage / GS Designs]

posted by Nisha – Israel, 2015-09-17 22:27 (3576 d 22:35 ago) – Posting: # 15424
Views: 6,390

Hi ElMaestro,
Many thanks for your prompt response.

❝ good to hear the 2-stage approaches have not drawn their last breath.

May I ask why it is not so commonly used?

❝ You would still be analysing AUCt and Cmax at stage II if one such is conducted, even if AUCt has been shown BE at stage I.

What about a case in which AUC doesn't meet the BE criteria at stage I, but its power is >80% due to the low ISCV, while Cmax power is <80%? Could we still continue to stage II?

Thanks again,
Nisha

Complete thread:

Different power of AUC vs. Cmax at stage I - continuation rules Nisha 2015-09-17 13:28 [Two-Stage / GS Designs]
- Different power of AUC vs. Cmax at stage I - continuation rules ElMaestro 2015-09-17 13:56
  - Different power of AUC vs. Cmax at stage I - continuation rulesNisha 2015-09-17 20:27
    - AUC vs. Cmax ElMaestro 2015-09-17 21:53
    - Assumption Helmut 2015-09-18 00:15