Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products - Scientific guideline

This document addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug development.

Keywords: Pharmacogenetics, pharmacokinetics, clinical development

Current effective version

Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Adopted Reference Number: EMA/CHMP/37646/2009 Legal effective date: 01/08/2012 Summary:

This guideline addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug development. For those cases where pharmacogenetics is envisioned to play a major role in the benefit-risk of a medicinal product because of its impact on pharmacokinetics, guidance is given regarding studies required and recommended at different phases of drug development to ensure satisfactory efficacy and safety in genetic subpopulations that have variable systemic exposure of active substances.

Document history - First version (current)

Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Adopted Reference Number: EMA/CHMP/37646/2009 Legal effective date: 01/08/2012 Summary:

This guideline addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug development. For those cases where pharmacogenetics is envisioned to play a major role in the benefit-risk of a medicinal product because of its impact on pharmacokinetics, guidance is given regarding studies required and recommended at different phases of drug development to ensure satisfactory efficacy and safety in genetic subpopulations that have variable systemic exposure of active substances.

Draft guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Draft: consultation closed Consultation dates: 22/04/2010 to 31/10/2010 Reference Number: EMA/CHMP/37646/2009

Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (E...

Draft: consultation closed Consultation dates: 10/07/2017 to 10/10/2017 Reference Number: EMA/CHMP/644998/2016 Summary:

This addendum to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) intends to provide clear definitions of terms used for metabolic phenotyping, as well to propose concepts regarding the translation of genotypes into the predicted metabolic phenotype, of significant importance for the correct treatment of patients.

Superseded documents

Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products

Adopted Reference Number: EMEA/128517/2006 Legal effective date: 01/05/2007

Overview of comments received on draft reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products (EMEA/128517/2006)

Reference Number: EMEA/19720/2007

Draft reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products

Draft: consultation closed Reference Number: EMEA/128517/2006