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 clarifies the requirements related to the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products. It applies predominantly to small molecule drugs as genetic effects on the pharmacokinetics of biological drugs today are much less understood.


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


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