Exclusion due to adverse event [Design Issues]

posted by Loky do – Egypt, 2021-03-29 15:59 (416 d 03:36 ago) – Posting: # 22297
Views: 1,631

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]

Complete thread:

UA Flag
Activity
 Admin contact
22,084 posts in 4,629 threads, 1,566 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Thursday 19:36 CEST (Europe/Vienna)

That which is not controversial
is of no particular interest.    Johann Wolfgang von Goethe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5