Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific guideline
Table of contents
This document underlines the specific problems related to the pharmacokinetics of protein products that need careful consideration during drug development.
Keywords: Therapeutic proteins, pharmacokinetics
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Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (PDF/97.67 KB)
Adopted
First published: 24/01/2007
Last updated: 24/01/2007
Legal effective date: 31/07/2007
CHMP/EWP/89249/2004 -
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Overview of comments received on draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (PDF/214.34 KB)
First published: 24/01/2007
Last updated: 24/01/2007
EMEA/CHMP/EWP/EMEA/198957/2006 -
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Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (PDF/100.95 KB)
Draft: consultation closed
First published: 27/07/2005
Last updated: 27/07/2005
EMEA/CHMP/89249/2004