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

posted by Elena777 – Belarus, 2019-09-16 19:48  – Posting: # 20601
Views: 1,723

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?

Complete thread:

Activity
 Admin contact
20,140 posts in 4,247 threads, 1,386 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 04:30 CET

The scientific spirit is of more value than its products,
and irrationally held truths may be more harmful
than reasoned errors.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5