CI inclusion ≠ TOST [BE/BA News]

posted by ElMaestro  – Denmark, 2020-12-05 17:49 (1409 d 12:34 ago) – Posting: # 22118
Views: 4,982

Haha,

❝ if the CI inclusion rule is really something different than TOST why do we calculate power / samplesize based on TOST :confused:.


d_labes, you beat me to it, I was going to ask a similar question. :-D

If I am getting it right this isn't about whether your product passes the test for BE or not, it is purely a matter relating to what you call it. Since semantics is now of such importance, I believe PowerTOST needs to be renamed.:cool:

Now someone kindly define robust and robustness for me so that I understand it. And please tell me how to use that definition to make a simulation robust enough that it convinces WHO :-)
Or more generally, if I want to present an argument to a WHO regulator (not a simulation but just an argument which may or may not be based on siumulation) in which way will I know away to make my argument robust?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,255 posts in 4,886 threads, 1,673 registered users;
87 visitors (1 registered, 86 guests [including 10 identified bots]).
Forum time: 07:23 CEST (Europe/Vienna)

Tortured data will confess to anything.    Fredric Menger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5