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

posted by ping4santosh  – India, 2020-03-11 16:15 (836 d 13:32 ago) – Posting: # 21254
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Hi ElMaestro,

It's not a random flutter. Females actually fall back on bioequivalncy. Cmax at 75% and range was lower too. Pioneer product behaved similar way. So it's not random. You are right. The females also has higher variance.

I didn't understand your last statement. Can you kindly clarify?

» Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated

Cheers,

SKM

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