Bioequivalence and Bioavailability Forum

Dear M.tareq,

❝ Another question does the side of the body mean right or left side of the body will contribute to variability between test to reference? or the model should include another factor for grouping based on right / left side of the body if the subjects were divided into left side injection and right side ? according to spc : alternate injection sites between sides of the body ?

I don't think so. Sites of injection (gluteal and deltoid) is meant IMHO, and right or left side should not play any role. Alternate injection sites between sides of the body is IMHO meant to protect the participants from local reactions due to too often injections in the same areal.
Or do you expect any differences between left and right side of the body? If yes why? Left and right are categories not known by the treatments to be applied. So why should there differences to be accounted for in the evaluation model?