But what is the real problem? [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2018-06-07 13:53 (957 d 18:09 ago) – Posting: # 18863
Views: 3,219

Hi Yura,

you do your study as best you can, making some assumoptions -good or bad- about GMR and CV.
At the end of the day you may show BE or not, and if you do, then it may be with a large or small margin. I guess forced BE just means the margin was large whatever that means quantitatively.
There is no real issue here. The discussions I have seen about BE consider forced BE as a hindsight phenomenon, like post-hoc power.

If you start fiddling with "forced BE" being convincingly planned before a trial then I would of course oppose it.

Remember: In principle, either the product is BE or it isn't. There just happens to be some uncertainty on the degree by which we can demonstrate it.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,306 posts in 4,443 threads, 1,489 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Wednesday 07:02 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