apple tree for two-stage [Two-Stage / GS Designs]

posted by Astea – Russia, 2019-09-16 20:39  – Posting: # 20602
Views: 2,013

Dear Elena777!

» tree?

I meant decision scheme (in graph theory mathematicians call "trees" undirected graphs). See also this message.

» 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?

In this situation we still have to go to the next stage. As it was shown before the fail for AUC (if it has less variability than Cmax) in the second stage is very unlikely. So it just doesn't matter what was CI for AUC after the first stage, the second stage for Cmax should be crucial.

"Being in minority, even a minority of one, did not make you mad"

Complete thread:

Activity
 Admin contact
20,237 posts in 4,258 threads, 1,396 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 06:39 CET

Nothing shocks me. I’m a scientist.    Harrison Ford (as Indiana Jones)

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