Food Effect Bioavailability Comparison [Design Issues]

posted by jag009  – NJ, 2014-05-07 22:48 (4435 d 09:45 ago) – Posting: # 12924
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❝ Usually when studying a food effect the study is performed as a two way crossover study in the morning (fed v fasted). If the study drug formulation …


Evening as in 8pM fasted and then give breakfast at 8am in the morning? That is 12 hours. I doubt you will see a difference between fast & fed (but I could be wrong). I have done nighttime dosing study for a product to be dose in the evening but the food effect study for that submission was a regular 2-way food effect (fast vs fed) study.

John

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