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

posted by ElMaestro  – Denmark, 2020-03-15 10:27 (1446 d 11:46 ago) – Posting: # 21273
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Hi ping,

❝ 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?


This could be a case of BE being present in males and not in females. Would you really want to put such a product on the market, if you think the conclusion from males can be extrapolated in such a way that regulators grant approval??
However, those companies that did try to investigate if BE applies in one population but not in another all failed - there are occasional rumours out there but the proof is generally rather absent. I.e. if a product is BE in one gender and not in another, or if a product is BE in a European population but not in an African population etc. Innovators have spent a lot of $$ on investigating it, and no solid proof was delivered so far.
I am thus a little doubtful as to whether you are really having a product with a true gender difference in terms of the BE conclusion.

"More data is needed."

Pass or fail!
ElMaestro

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