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 (EMA/CHMP/37646/2009)

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Download document 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 (EMA/CHMP/37646/2009)
Reference number EMA/CHMP/644998/2016
Status draft: consultation open
First published 2017-07-07
Last updated 2017-07-07
Consultation start date 2017-07-10
Consultation end date 2017-10-10
Email address for submissions pgwpsecretariat@ema.europa.eu

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.