Two tests and one reference [General Sta­tis­tics]

posted by Brus – Spain, 2020-08-31 09:58 (185 d 08:34 ago) – Posting: # 21895
Views: 3,108

Dear Helmut and all,

If one test and two references of different regions are tested in a bioequivalence study, is it necessary a α adjustment?

In my case, we want to demonstrate if the test product is bioequivalent to R1 (European product reference) or if test product is bioequivalent to R2 (Reference product in the United Kingdom).

If I have not misunderstood, in this case, alpha should be penalized, even if they are from different regions and to market in different regions because of the word "OR"?

Is there a way to not penalize alpha? If the "O" is changed to "AND"? Executing two different clinical trials (one for Europe and one for the UK)?

Best regards,

Complete thread:

Activity
 Admin contact
21,363 posts in 4,462 threads, 1,492 registered users;
online 8 (0 registered, 8 guests [including 8 identified bots]).
Forum time: Thursday 17:33 CET (Europe/Vienna)

Being really good at C++ is like being really good
at using rocks to sharpen sticks.    Thant Tessman

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