State it in the SAP & observe it [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-03-29 20:08 (616 d 03:12 ago) – Posting: # 22298
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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 tmax:-D 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.

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