Clinical investigation of the pharmacokinetics of therapeutic proteins

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Current effective version

Adopted guideline

Reference numberCPMP/EWP/89249/04
Published24/01/2007
Effective from31/07/2007
KeywordsTherapeutic proteins, pharmacokinetics
DescriptionThis document underlines the specific problems related to the pharmacokinetics of protein products that need careful consideration during drug development.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 31/07/2007–present


Published: 24/01/2007


Published: 27/07/2005


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