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Back to the forum  2018-06-22 19:06 CEST (UTC+2h)

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

posted by ElMaestro - Denmark, 2017-09-08 17:24  - Posting: # 17795
Views: 2,974

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.

if (3) 4

Best regards,

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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