Sequential trial with B method of Potvin [Two-Stage / GS Designs]

posted by john john – Spain, 2015-10-01 19:44 (3100 d 21:30 ago) – Posting: # 15513
Views: 12,088

In a sequential clinical trial conducted like a B method of Potvin, we have Cmax and AUC both not bioequivalent. Cmax has a power <80% (71.5%), and AUC>80% (84.6%).
AUC 0-30min calculated by protocol is bioequivalent.
In the protocol it was not specified how to proceed in this situation.

Can we calculate a new n and pass to the second phase? Or we must stop the trial?

Thanks


Edit: Category changed. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
79 visitors (0 registered, 79 guests [including 11 identified bots]).
Forum time: 16:14 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