Why BE testing use 90 CI [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2019-02-23 10:18  – Posting: # 19968
Views: 580

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?

if (3) 4

x=c("Foo", "Bar")
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1

Best regards,

“(...) 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:

 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,408 posts in 4,123 threads, 1,325 registered users;
online 5 (1 registered, 4 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 12:44 CEST

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

BEBAC Ing. Helmut Schütz