BE Studies involving Multiple Groups [General Statistics]
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
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
Kind regards and have a nice day
Dr_Dan
Complete thread:
- BE Studies involving Multiple Groups jag009 2014-08-05 19:34
- BE Studies involving Multiple Groups ElMaestro 2014-08-05 23:13
- BE Studies involving Multiple GroupsDr_Dan 2014-08-06 07:55
- BE Studies involving Multiple Groups jag009 2014-08-08 16:49
- BE Studies involving Multiple Groups Dr_Dan 2014-08-10 23:59
- BE Studies involving Multiple Groups pash413 2014-08-18 08:26
- BE Studies involving Multiple Groups Dr_Dan 2014-08-10 23:59
- BE Studies involving Multiple Groups ElMaestro 2014-08-05 23:13
