‘Method C’ ⇒ risky [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 16:15 (374 d 09:13 ago) – Posting: # 20622
Views: 4,001

Hi Elena,

» This is our first experience in conducting such studies, so we are quite excited. :lookaround:

Keep in mind that it might also be the first experience for the experts of the agencies you are aiming at. Possibly they have heard about the skeptic attitudes of European assessors towards ‘Method C’. Consider ‘Method B’ instead. See the end of this post for a comparison of power. What will it help to have (maybe) two subject less in the second stage and a study which is not accepted? I warned you. :cool:

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,079 posts in 4,396 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 01:29 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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