Two tests and one reference [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2020-08-31 10:23 (86 d 11:23 ago) – Posting: # 21896
Views: 2,589

Hi Brus,

» 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)?

Here's a different way to look at it:
Can the same patient(s) be affected by your two tests? If yes, it is safer to use correction. If no, no correction should be necessary.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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