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

posted by ElMaestro  – Denmark, 2017-11-14 00:04 (1163 d 06:47 ago) – Posting: # 17976
Views: 6,702

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.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,306 posts in 4,443 threads, 1,489 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: Wednesday 06:51 CET (Europe/Vienna)

Power: That which is wielded by the priesthood of
clinical trials, the statisticians, and a stick which they use
to beta their colleagues.    Stephen Senn

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