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Back to the forum  2018-06-20 07:58 CEST (UTC+2h)

Enlighten me please [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-09-06 21:11  - Posting: # 17787
Views: 1,903

Hi guys(and girls),

What is your opinion on this guidance about BE needs to be demonstrated for 2 active metabolites and not the parent? They want all three measured too.

The parent is rapidly absorbed from a 600mg dose, with a peak plasma concentration of 1.98 mg/l occurring approximately 90 minutes after ingestion. The absolute bioavailability of a 20 mg oral dose is 69%. The parent is primarily via pathways involving N-demethylation and terminal hydroxylation... In vitro studies have shown that CYP450 3A4 is primarily responsible for the metabolism....

I don't get it. The message has always been (or almost always been) to show BE for parent if it can be accurately quantified since it is the one that gets absorbed. Someone was :party: when the document was written?


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