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

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 14:15  – Posting: # 20622
Views: 3,430

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
20,810 posts in 4,355 threads, 1,447 registered users;
online 16 (1 registered, 15 guests [including 10 identified bots]).
Forum time: 03:15 UTC (Europe/Vienna)

One of the symptoms of an approaching nervous breakdown
is the belief that one’s work is terribly important.    Bertrand Russell

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