The European Medicines Agency has recently issued a new “Guideline on the use of pharmacogenetic methodologies in the pharmacokinetics evaluation of medicinal products”.

This document clarifies the requirements to carry out pharmacogenetics studies during early stages of clinical development, as well as detailing in which cases the implementation of these studies is recommended. Furthermore, it offers advice on study design, analysis and interpretation of results, and its practical clinical application, among other relevant aspects.

The new directives replace the older ones set out by “Reflection paper on the use of Pharmacogenetics in the Pharmacokinetic Evaluation of Medicinal Products” of 2006, and will be effective beginning August 1,this year.