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RegisterFasting & Fed Study based on USFDA Guidelines [Regulatives / Guidelines]
Hi everyone,
It seems that USFDA did require both fasting & fed study for most of the molecules. May I know on what basis they provide such recommendation?
Can I skip fed study and perform fasting study only?
Kindly advise.
Many thanks.
It seems that USFDA did require both fasting & fed study for most of the molecules. May I know on what basis they provide such recommendation?
Can I skip fed study and perform fasting study only?
Kindly advise.
Many thanks.
Complete thread:
- Fasting & Fed Study based on USFDA GuidelinesMei San 2016-10-24 04:29 [Regulatives / Guidelines]
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- ANDA Submissions – Refuse-to-Receive Standards Helmut 2016-10-24 10:06
- Fasting & Fed Study based on USFDA Guidelines jag009 2016-12-18 07:37
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