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Back to the forum  Query: 2017-11-23 19:24 CET (UTC+1h)

Sample size for FDA's in vitro population BE [Power / Sample Size]

posted by ElMaestro - Denmark, 2017-09-08 17:24  - Posting: # 17795
Views: 1,081

Hi all,

here's the pretty solution to a terrible challenge, originating from this guidance and which is now applied to about 40 different products.

It basically involves the application of an idea that is 40 years old and which was totally impractical at the time it was invented, and using it on FDA's pop BE approach. No-one has been able to deal with it analytically because the math gets too complicated (in fact, FDA's way to calculate the confidence limit for Eta is in itself an approximation).


A good weekend to all of you.

I could be wrong, but…

Best regards,

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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