Restrictions on Subjects Movement during BE [Design Issues]

posted by joyjac – Philippines, 2006-06-28 08:56 (6483 d 11:49 ago) – Posting: # 157
Views: 7,092

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
22,957 posts in 4,819 threads, 1,636 registered users;
83 visitors (0 registered, 83 guests [including 7 identified bots]).
Forum time: 19:46 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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