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

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.