Underrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-03-15 07:30 (312 d 01:40 ago) – Posting: # 21272
Views: 3,213


» Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.

FDA? Even if not FDA I don't think your justification will work. You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.


Complete thread:

 Admin contact
21,308 posts in 4,444 threads, 1,488 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Thursday 09:11 CET (Europe/Vienna)

Politicians use statistics like drunkards use lampposts:
not for illumination, but for support.    attributed to Hans Kuhn

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