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

posted by Ohlbe – France, 2020-03-11 15:07 (625 d 10:19 ago) – Posting: # 21251
Views: 3,915

Dear SKM,

» We have done a pilot study with 12 subjects (8 male and 4 female) and the results didn't meet the bioequivalence criteria.

So what ? It is a pilot. Was it powered to demonstrate BE ?

» However, when we exclude the female data it marginally meets the bioequivalency criteria of 80%-125%.

Did you pre-plan this male-only analysis in your protocol or statistical analysis plan ?

» Can we conduct the pivotal study only in Males?

Where do you intend to submit your data ? USA: the FDA wants males and females. Europe: EMA accepts studies in males only, but "we fear that we may fail if we include females" will not be an acceptable rationale.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,778 posts in 4,555 threads, 1,547 registered users;
online 10 (0 registered, 10 guests [including 1 identified bots]).
Forum time: Saturday 01:26 CET (Europe/Vienna)

Every new technology to me is like a newborn baby –
and you think that it’s become president
or it’s cure cancer or win a nobel prize.
But in the end, you’re perfectly happy
when it just stays out of jail […].    Eric Betzig

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