State it in the SAP & observe it [Design Issues]
❝ 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 tmax. 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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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