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

posted by Nisha – Israel, 2015-09-17 15:28 (3115 d 03:51 ago) – Posting: # 15419
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Hi all,
I would like to raise a scenario following stage I results with Potvin C:

If, hypothetically, our results at stage I would have had good ratio, and failed to meet 94.12% CI BE criteria at stage I for both Cmax and AUC.
The power analysis would have shown results higher than 80% for AUC, and lower than 80% for Cmax. Based on Cmax, we could continue to stage II. In that case - what would be the practice for AUC? I would assume it would have been calculated also for stage II. How should this be covered in the protocol?

Would appreciate your input.

Many thanks,
Nisha

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