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

posted by ping4santosh  – India, 2020-03-15 09:43 (400 d 10:51 ago) – Posting: # 21275
Views: 3,340

» 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
21,419 posts in 4,475 threads, 1,510 registered users;
online 23 (0 registered, 23 guests [including 2 identified bots]).
Forum time: Monday 21:34 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