diarrhea in Extended release study [Outliers]
❝ (...) if I have a study on product containing two actives (one IR and the other extended release) and a participant had a diarrhea after Tmax of the IR active and through the Tmax of the XR active. should I exclude the participant from the study? or include him in the XR active statistical calculation and exclude in the IR?
Yes, the only reason this question is relevant up is that Sponsors have not begun to adhere to the policy of pharmacokinetic solidarity
Here's how I would approach it:
1. Act according to the protocol.
2. If nothing is stated in the protocol about this situation, act in accordance with SOPs.
3. If nothing in stated in SOPs about this situation, let the PI (and none other than the PI!) judge the case, decide and document the basis for her/his decision.
Judging the case for example means the PI (un-coercedly) should decide if inclusion data arising from the subject in question helps fulfill the purpose of the trial.
Oftentimes, if you are doing BE with two active treatments with just two periods, then exclusion of one period for a subject means that subject is entirely lost for the purposes of stats.
You did not mention where you are submitting the dossier, but national guidelines may apply as well.
Pass or fail!