Bioequivalence and Bioavailability Forum

Hi Loky do,

❝ If subject during bioequivalence study suffered from diarrhea before 2 median Tmax of immediate-release drug product, in this case, the optimum action to be done to exclude the subject from the study after the event directly?

If you know the median t_max.  Sometimes in the label / SmPC for unfathomable reasons the mean is given.
State in the statistical analysis plan, and follow it (analyse the samples anyway).

❝ or subject continues the study and excludes his results from the calculations if his plasma concentration-time profile is unreliable?

I would not recommend that. Who / how decides what is ‘unreliable’? May lead to endless & fruitless discussions.