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

posted by Mei San – Malaysia, 2016-10-24 06:29 (3036 d 04:50 ago) – Posting: # 16750
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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.

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