Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-20 07:16 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: 2,954

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,
ElMaestro

"(...) 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.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,395 posts in 3,909 threads, 1,174 registered users;
online 35 (0 registered, 35 guests [including 19 identified bots]).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed