Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Current effective version

PDF iconAdopted 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

PDF iconAdopted guideline

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/08/2012–present

Published: 06/05/2010

Published: 23/04/2009

Superseded document

PDF iconReflection paper

PDF iconOverview of comments

PDF iconDraft reflection paper

Published: 25/05/2007

Published: 24/05/2007

Published: 01/07/2006

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