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

posted by Elena777 – Belarus, 2019-09-16 19:48 (330 d 19:13 ago) – Posting: # 20601
Views: 3,996

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
21,006 posts in 4,379 threads, 1,460 registered users;
online 11 (2 registered, 9 guests [including 4 identified bots]).
Forum time: Wednesday 15:01 CEST (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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