BE Studies involving Multiple Groups [General Sta­tis­tics]

posted by Dr_Dan  – Germany, 2014-08-06 09:55 (4341 d 10:38 ago) – Posting: # 13342
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Dear John,
I totally agree with ElMaestro. If you assess the groups separately you will have inflated 90%CI due to the lower number of subjects. Therefore a partial overlap with acceptance range should be no problem and to my experience this is the usual outcome. If you have no overlap with acceptance range you have shown for your product that (at least for this group) it is bioinequivalent. This group effect is a showstopper as long as you have no reasonable explanation for the different behavior of this group.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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