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

posted by ping4santosh  – India, 2020-03-15 10:43 (1446 d 11:15 ago) – Posting: # 21275
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❝ You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.


Hi Jag,

Thanks for your suggestion. What do you think should be the ratio of M:Fe, wherein you know that more female you take, the more closer you get to bioinequivalency. Whats your take?

Cheers,
SKM


Edit: Standard quotes restored; see also this post #8[Helmut]

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