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

posted by Ohlbe – France, 2020-03-11 14:07 (407 d 21:30 ago) – Posting: # 21251
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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

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