multiple dose studies [Regulatives / Guidelines]

posted by dshah  – India, 2024-01-22 11:03 (875 d 06:52 ago) – Posting: # 23836
Views: 4,218

Dear Loky do!

It will be good to confine the subjects which can confirm that subject have taken dose on recommended time, not missed any dose, food is standardized (high fat/low fat/ standard food) and consumed by volunteers. There can be other things added- but if you plan not to confine till 7th day- how does that ensure that subjects have followed protocol compliance?

Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
108 visitors (0 registered, 108 guests [including 22 identified bots]).
Forum time: 18:56 CEST (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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