Different power of AUC vs. Cmax at stage I - continuation rules [Two-Stage / GS Designs]

posted by Nisha – Israel, 2015-09-17 15:28 (3115 d 22:50 ago) – Posting: # 15419
Views: 6,312

Hi all,
I would like to raise a scenario following stage I results with Potvin C:

If, hypothetically, our results at stage I would have had good ratio, and failed to meet 94.12% CI BE criteria at stage I for both Cmax and AUC.
The power analysis would have shown results higher than 80% for AUC, and lower than 80% for Cmax. Based on Cmax, we could continue to stage II. In that case - what would be the practice for AUC? I would assume it would have been calculated also for stage II. How should this be covered in the protocol?

Would appreciate your input.

Many thanks,
Nisha

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
100 visitors (0 registered, 100 guests [including 9 identified bots]).
Forum time: 13:19 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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