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

posted by jag009  – NJ, 2020-03-15 07:30 (400 d 02:52 ago) – Posting: # 21272
Views: 3,349

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
21,419 posts in 4,475 threads, 1,510 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Monday 11:23 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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