Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/37646/2009
Effective from01/08/2012
KeywordsPharmacogenetics, pharmacokinetics, clinical development
DescriptionThis document addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug development.

Document history

First version

Current version

Adopted guideline

Draft guideline

Concept paper

In operation: 01/08/2012–present

Published: 06/05/2010

Published: 23/04/2009

Superseded document


Reflection paper

Overview of comments

Draft reflection paper

Published: 25/05/2007

Published: 24/05/2007

Published: 01/07/2006

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