Restrictions on Subjects Movement during BE [Design Issues]

posted by joyjac – Philippines, 2006-06-28 08:56 (6945 d 23:42 ago) – Posting: # 157
Views: 9,064

Hi! I would like to get your thoughts on this. During the BE study, while lying in bed or in supine position is Not allowed after drug intake for at least 2 hours, can the volunteer subjects be allowed to stay standing, sitting or walking i.e. limited activity around the room where they stay after dose?

I understand that posture and physical activity of the subjects must be standardized, meals and fluid intake as well, during the study as the bioavailability of an active moiety from a dosage form could be dependent upon GI transit times, posture and physical activity.

I appreciate inputs on the above. Thanks.

Complete thread:

UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,679 registered users;
61 visitors (0 registered, 61 guests [including 35 identified bots]).
Forum time: 08:38 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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