Bioequivalence and Bioavailability Forum

Hi d_labes,

I'd just like to add a little on basis of what's specified in ICH E9, page 12.
Basically, the document gives two reasons for using multiple centers
1. Recruitment/speed issues
2. Generalisation
Your situation is in my opinion covered by the first reason and not at all by the second (because you have no reason to generalise anything related to contre diversity, and that's also why center should imho be fixed, not random, in case it's to be included in the evaluation; but this is an issue that applies more frequently to originator drugs).

To me most of chapter 3.2 must have been written with superiority trials in mind, not equivalence.

Best regards,
EM.

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Edit: ICH-E9 linked. [Helmut]