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

posted by ping4santosh  – India, 2020-03-15 09:43 (199 d 01:28 ago) – Posting: # 21275
Views: 3,044

» You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.

Hi Jag,

Thanks for your suggestion. What do you think should be the ratio of M:Fe, wherein you know that more female you take, the more closer you get to bioinequivalency. Whats your take?

Cheers,
SKM


Edit: Standard quotes restored; see also this post #8[Helmut]

Complete thread:

Activity
 Admin contact
21,087 posts in 4,398 threads, 1,468 registered users;
online 43 (0 registered, 43 guests [including 5 identified bots]).
Forum time: Wednesday 12:11 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