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

posted by Nisha – Israel, 2015-09-17 22:27 (3431 d 19:10 ago) – Posting: # 15424
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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

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