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

posted by jag009  – NJ, 2020-03-15 07:30 (199 d 12:29 ago) – Posting: # 21272
Views: 3,063

Hi,

» 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.

J

Complete thread:

Activity
 Admin contact
21,090 posts in 4,398 threads, 1,469 registered users;
online 23 (0 registered, 23 guests [including 7 identified bots]).
Forum time: Wednesday 20:59 CEST (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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