n2 based on PK metric with higher CV [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-16 17:48  – Posting: # 20601
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Dear Helmut,

Still need some clarifications on the question from Astea:

» a) first step - estimated power is less than target (80%) for Cmax and more than target for AUC, besides 90%CI for AUC is OK.

To be in compliance with method C of Potvin, we re-calculate CI for Cmax with α=0,0294. Let`s assume that BE criterion for Cmax is met after this step. Should we also re-calculate CI for AUC with α=0,0294? Otherwise, finally we will have the following in a CSR: BE criterion was met for AUC using α=0,05 (90%CI) and BE criterion was met for Cmax using α=0,0294 (94,12% CI). Does it look OK?

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