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

posted by ElMaestro  – Denmark, 2017-11-14 01:04 (2326 d 10:25 ago) – Posting: # 17976
Views: 8,587

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
108 visitors (0 registered, 108 guests [including 6 identified bots]).
Forum time: 11:29 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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