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
- Clinical pharmacology and pharmacokinetics
- Directive 2001/83/EC
Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party- Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function
- Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
- ICH E3 Structure and content of clinical study reports
- ICH E6 (R1) Good clinical practice
- ICH E8 General considerations for clinical trials
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Investigation of bioequivalence
- Investigation of drug interactions
- Pharmacokinetic studies in man