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

posted by ping4santosh  – India, 2020-03-11 14:35  – Posting: # 21247
Views: 4,157

Dear All,

I request your help to arrive at a decision on male to female ratio in a BE trial. We have done a pilot study with 12 subjects (8 male and 4 female) and the results didn't meet the bioequivalence criteria. However, when we exclude the female data it marginally meets the bioequivalency crtieria of 80%-125%.

Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.

Thanks a lot for your support.
Best wishes,
SKM

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