Exclusion due to adverse event [Design Issues]

posted by Loky do – Egypt, 2021-03-29 15:59 (18 d 14:23 ago) – Posting: # 22297
Views: 354

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:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,508 registered users;
online 8 (0 registered, 8 guests [including 2 identified bots]).
Forum time: Saturday 06:23 CEST (Europe/Vienna)

I never did anything worth doing by accident,
nor did any of my inventions come by accident;
they came by work.    Thomas Alva Edison

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