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RegisterFasting & Fed Study based on USFDA Guidelines [Regulatives / Guidelines]
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
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
Complete thread:
- Fasting & Fed Study based on USFDA Guidelines Mei San 2016-10-24 04:29 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANDA Submissions – Refuse-to-Receive Standards Helmut 2016-10-24 10:06
- Fasting & Fed Study based on USFDA Guidelinesjag009 2016-12-18 07:37
Ing. Helmut Schütz