Why BE testing use 90 CI [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2019-02-23 10:18  – Posting: # 19968
Views: 1,686

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?

Le tits now.

Best regards,
ElMaestro

Complete thread:

Activity
 Admin contact
20,253 posts in 4,262 threads, 1,398 registered users;
online 13 (1 registered, 12 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 20:24 CET

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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