Center term in Bioequivalence Study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2022-06-08 15:14 (770 d 12:48 ago) – Posting: # 23048
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Hi balakotu,

in the circumstance, however regrettable the situation is, you have to deal with it.
Perhaps I would lump centers with less than x subjects into one supercenter with a certain lump size. This is a common thing to do in certain equivalence studies and it has acceptance in both US and EU (but mind you, these things should ideally, as Helmut gently hints at, be pre-specified).

Go for x=6 or 8 or something. But you're in for a barrage of questions whatever you do.

Pass or fail!
ElMaestro

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