Restrictions on Subjects Movement during BE [Design Issues]
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.
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:
- Restrictions on Subjects Movement during BEjoyjac 2006-06-28 06:56 [Design Issues]
- Restrictions on Subjects Movement during BE Helmut 2006-07-05 14:54