diarrhea in Extended release study [Outliers]

posted by ElMaestro  – Belgium?, 2020-09-24 13:18 (72 d 10:39 ago) – Posting: # 21937
Views: 262

Hi researcher101,

» (...) 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? :confused:

Shit happens :cool:

Yes, the only reason this question is relevant up is that Sponsors have not begun to adhere to the policy of pharmacokinetic solidarity :-D

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!

Complete thread:

 Admin contact
21,243 posts in 4,431 threads, 1,483 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Saturday 22:58 CET (Europe/Vienna)

I believe there is no philosophical high-road in science,
with epistemological signposts. No, we are in a jungle
and find our way by trial and error,
building our road behind us as we proceed.    Max Born

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz