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

posted by Helmut Homepage – Vienna, Austria, 2019-09-19 18:15 (1852 d 14:11 ago) – Posting: # 20622
Views: 10,609

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,257 posts in 4,886 threads, 1,673 registered users;
72 visitors (1 registered, 71 guests [including 7 identified bots]).
Forum time: 08:26 CEST (Europe/Vienna)

Tortured data will confess to anything.    Fredric Menger

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