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

posted by ping4santosh  – India, 2020-03-11 16:15 (500 d 09:40 ago) – Posting: # 21254
Views: 3,734

Hi ElMaestro,

It's not a random flutter. Females actually fall back on bioequivalncy. Cmax at 75% and range was lower too. Pioneer product behaved similar way. So it's not random. You are right. The females also has higher variance.

I didn't understand your last statement. Can you kindly clarify?

» Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated

Cheers,

SKM

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Sunday 02:55 CEST (Europe/Vienna)

Maturity is the capacity to endure uncertainty.    John Finley

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