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 - Scientific guideline

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.

Keywords: Phenotype, genotype, methodologies, pharmacokinetics, metabolism

Current effective version

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.