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RegisterCenter term in Bioequivalence Study [Study Assessment]
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.
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
Pass or fail!
ElMaestro
Complete thread:
- Center term in Bioequivalence Study balakotu 2022-06-08 08:03 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Few subjects and many centers… Helmut 2022-06-08 11:56
- Center term in Bioequivalence StudyElMaestro 2022-06-08 13:14
Ing. Helmut Schütz