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

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 16:15 (432 d 03:21 ago) – Posting: # 20622
Views: 4,193

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
21,206 posts in 4,425 threads, 1,481 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Tuesday 18:37 CET (Europe/Vienna)

All we know about the world teaches us that the effects of A and B
are always different—in some decimal place—for any A and B.
Thus asking “are the effects different?” is foolish.    John W. Tukey

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