Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific guideline

HumanScientific guidelines

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This document underlines the specific problems related to the pharmacokinetics of protein products that need careful consideration during drug development.

Keywords: Therapeutic proteins, pharmacokinetics

Current effective version

Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

Adopted Reference Number: CHMP/EWP/89249/2004 Legal effective date:

English (EN) (97.67 Ko - PDF)

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Document history - First version (current)

Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

Adopted Reference Number: CHMP/EWP/89249/2004 Legal effective date:

English (EN) (97.67 Ko - PDF)

Première publication: Dernière mise à jour:
Voir

Overview of comments received on draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

Reference Number: EMEA/CHMP/EWP/EMEA/198957/2006

English (EN) (214.34 Ko - PDF)

Première publication: Dernière mise à jour:
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Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

Draft: consultation closed Reference Number: EMEA/CHMP/89249/2004

English (EN) (100.95 Ko - PDF)

Première publication: Dernière mise à jour:
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