PAR not yet [Two-Stage / GS Designs]

posted by The Outlaw Torn – Europe, 2011-10-27 11:07 (3486 d 10:19 ago) – Posting: # 7551
Views: 12,934

Hello all,

We provided our protocol to a central European country and this is what they responded about Potvin method C:

“Method C” as proposed in this publication is not acceptable, as type I error is not controlled on the 5% level and alternative methods securing type I error control are available.

They go on to suggest method B because "The authors demonstrate by simulations that the power of this method is only slightly lower than for “Method C”, resulting in comparable mean total number of subjects."

Any comments?


Complete thread:

 Admin contact
21,460 posts in 4,486 threads, 1,511 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Thursday 21:27 CEST (Europe/Vienna)

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

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