Loky do
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Egypt,
2021-03-29 15:59
(22 d 05:49 ago)

Posting: # 22297
Views: 804
 

 Exclusion 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]
Helmut
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Vienna, Austria,
2021-03-29 18:08
(22 d 03:40 ago)

@ Loky do
Posting: # 22298
Views: 607
 

 State it in the SAP & observe it

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.

Dif-tor heh smusma 🖖
Helmut Schütz
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dshah
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India,
2021-03-31 14:43
(20 d 07:05 ago)

@ Loky do
Posting: # 22299
Views: 550
 

 Exclusion due to adverse event

Dear Loky do,
It is always beneficial to mention exclusion parameters in Protocol.
Generally diarrhea is going to impact gastric motility and thus absorption of drug. PI shall exclude such subjects.
Regards,
Dshah
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