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

posted by ElMaestro  – Denmark, 2020-03-15 10:23 (424 d 08:24 ago) – Posting: # 21277
Views: 3,404

(edited by ElMaestro on 2020-03-15 10:37)

Dear ping,

» This could be a case of BE being present in males and not in females....
» In fact that's the case in the pilot. Please let me know what specific data you need?

I think I may -again- have formulated myself sub-optimally and for this I apologise.
I can't imagine that you have solid data to document that the conclusion changes between genders, but please prove me wrong.
Note that BE studies have three outcomes: BE, BE not shown (inconclusive), and bioinequivalent. I would be very astonished if you have data to show bioequivalence in one gender and bioinequivalence in the other. More likely -this is speculation on my part- you have an overlap with the acceptance range in which case you are inconclusive for that interval or population.

BE not shown in females while BE shown in males is in itself not necessarily a proof that the conclusion changes between genders.

So... SDTM+ADAM, please?
Can you show intervals, and sample sizes?

Pass or fail!

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