Two tests and one reference [General Sta­tis­tics]

posted by Brus – Spain, 2020-08-31 07:58 (86 d 11:13 ago) – Posting: # 21895
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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,

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