Postural restriction [Design Issues]

posted by jag009  – NJ, 2018-03-23 16:39 (1310 d 12:04 ago) – Posting: # 18591
Views: 4,326

» As per your above mentioned post, the statement state that, 02 or 01 hour postural restriction useful for floating the tablet. But considering the PK (absorption) point of view, for example drug cmax is 4 hours. if we kept 02 hours restriction. after 02 hours if subject will move that will impact on the absorption phase of drug. so better we need keep 04 hours and followed up to Tmax.

Note that my previous reply is for night dosing (10pm). We were dosing chrono-technology drug which Tmax at 6 hours and designed to be given at night. You can't ask the subject to restrict his posture throughout the night.

» Now, My question is if Tmax 6 hours, we cant tell to subject follow the 6 hours postural restriction. But considering absorption phase it will be required. This cases what wee need to do.

Yes and no. If you go by Tmax alone then it's kind of a flaw logic. An example drug is COVERA HS which as a Tmax of 11 hours. Are you going to ask the subjects to follow a 11 hour postural restriction?

J

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