Restrictions on Subjects Movement during BE [Design Issues]

posted by joyjac – Philippines, 2006-06-28 08:56 (6568 d 18:12 ago) – Posting: # 157
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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.

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