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

posted by ElMaestro  – Denmark, 2020-03-15 09:27 (504 d 13:06 ago) – Posting: # 21273
Views: 3,491

Hi ping,

» 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?

This could be a case of BE being present in males and not in females. Would you really want to put such a product on the market, if you think the conclusion from males can be extrapolated in such a way that regulators grant approval??
However, those companies that did try to investigate if BE applies in one population but not in another all failed - there are occasional rumours out there but the proof is generally rather absent. I.e. if a product is BE in one gender and not in another, or if a product is BE in a European population but not in an African population etc. Innovators have spent a lot of $$ on investigating it, and no solid proof was delivered so far.
I am thus a little doubtful as to whether you are really having a product with a true gender difference in terms of the BE conclusion.

"More data is needed."

Pass or fail!

Complete thread:

 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 23:33 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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