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
Published02/02/2012
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Superseded document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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