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

posted by Ohlbe – France, 2020-03-11 15:07  – Posting: # 21251
Views: 2,067

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
20,460 posts in 4,297 threads, 1,414 registered users;
online 17 (1 registered, 16 guests [including 12 identified bots]).
Forum time (Europe/Vienna): 21:39 CEST

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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