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RegisterSample size for FDA's in vitro population BE [Power / Sample Size]
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.
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.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Sample size for FDA's in vitro population BEElMaestro 2017-09-08 17:24
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- Sample size for FDA's in vitro population BE mahmoud-teaima 2017-09-10 16:12
- Sample size for FDA's in vitro population BE ElMaestro 2017-09-10 16:23
- Sample size for FDA's in vitro population BE mahmoud-teaima 2017-09-11 13:26
- Sample size for FDA's in vitro population BE ElMaestro 2017-09-10 16:23
- Extra-marital cohabitation Helmut 2017-09-08 18:05
Ing. Helmut Schütz