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

posted by ping4santosh  – India, 2020-03-11 16:15 (316 d 19:23 ago) – Posting: # 21254
Views: 3,464

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



Complete thread:

 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Friday 11:38 CET (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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