Why BE testing use 90 CI [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2019-02-23 10:18 (941 d 04:23 ago) – Posting: # 19968
Views: 3,693

Hi Akash,

» Why Bioequivalence testing makes use of the 90 CI why not 95 CI which gives more accuracy?

More accuracy, what does that mean?

We have some more or less empirically justified limits of 80.00%-125.00%.
And we want a 5% risk of making the wrong conclusions in the sense of regulatory (patient's) risk; in practice this means we adopt a policy of a 5% risk of approving a product that is not BE. This is where the 90% CI comes into the equation. There is a (not more than) 5% risk associated with it (1-2*alpha).

A 95% CI would be less risky, ie. up to 2.5% chance of approving a non-BE product. Why would we want that, then alpha=5% seems to work just fine?

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,691 posts in 4,534 threads, 1,541 registered users;
online 12 (0 registered, 12 guests [including 1 identified bots]).
Forum time: Tuesday 15:41 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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