Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Exclusion due to adverse event [Design Issues]

posted by dshah – India/United Kingdom, 2021-03-31 16:43 (677 d 15:15 ago) – Posting: # 22299
Views: 1,461

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

Complete thread:

Exclusion due to adverse event Loky do 2021-03-29 15:59 [Design Issues]
- State it in the SAP & observe it Helmut 2021-03-29 18:08
- Exclusion due to adverse eventdshah 2021-03-31 14:43

Admin contact
22,481 posts in 4,710 threads, 1,603 registered users;
33 visitors (0 registered, 33 guests [including 14 identified bots]).
Forum time: 06:58 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce. Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz