A better place to start. [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2017-11-13 23:04  – Posting: # 17976
Views: 5,545

Hi d_labes,

» But that's not the problem Helmut has described, at least as I understand it. Here we initiate a stage 2 from the perspective of the AUC evaluation where it is not neccessary to initiate one.

Best I can come up with is as follows:
The only thing that determines the need for for stage 2 is the CV.
AUCt is generally having a lower CV than Cmax (for the record, I said 'generally', I did not say 'always'). Often it is about 5-20 percentage points.

So run the sims in the usual fashion, but add 5-20 points on the CV for the power and sample size estimation.

Le tits now.

Best regards,
ElMaestro

Complete thread:

Activity
 Admin contact
20,237 posts in 4,258 threads, 1,396 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 23:58 UTC

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