Exclusion due to adverse event [Design Issues]

posted by Loky do – Egypt, 2021-03-29 15:59 (125 d 14:48 ago) – Posting: # 22297
Views: 1,203


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

Thanks in advance

Edit: Category changed; see also this post #1[Helmut]

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