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RegisterExclusion due to adverse event [Design Issues]
Dears
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]
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]
Complete thread:
- Exclusion due to adverse eventLoky do 2021-03-29 15:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- State it in the SAP & observe it Helmut 2021-03-29 18:08
- Exclusion due to adverse event dshah 2021-03-31 14:43
Ing. Helmut Schütz