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

posted by ping4santosh  – India, 2020-03-11 15:37 (201 d 01:05 ago) – Posting: # 21253
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» 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.

Dear Ohlbe,

Thanks you your response. The pilot was not powered. Pivotal is powered given the high ISCV. We didn't pre-plan it in the pilot. We took M:Fe in the ratio of 2:1 and this is a post hoc analysis. We saw high ISCV and lower Cmax in Females as compared to Males. We intend to submit the data in EU but I won't be surprised if the management decides to submit that data in FDA at a later date.

Should you suggest me to go ahead with same M:Fe::2:1 ratio for a powered pivotal?

Cheers, SKM

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