Fasting & Fed Study based on USFDA Guidelines [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-12-18 08:37 (2974 d 07:44 ago) – Posting: # 16853
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They play safe. If they don't ask for fed (unless there is safety issue) then what happens if your generic formulation has a food effect whereas the reference doesn't?

Another thing I hate about PM (product monograph) for some drugs is the lack of a no food effect sentence when the drug has no food effect. Some PM has it and some PM doesn't.

John

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