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

posted by Ohlbe – France, 2020-03-11 16:07 (1495 d 22:21 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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