Challenges and opportunities of pharmacogenetics in drug development

Abstract

Drugs fail the regulatory process for a variety of reasons, including issues with pharmacokinetics, safety and efficacy. One of the most exciting questions in drug development today is how far the science of pharmacogenetics, the study of the genetics of drug response, can be used to address the fundamental issues that the pharmaceutical industry is facing. In particular, the question of how far it is possible to use this emerging science to deliver the right treatment, to the right patient, at the right dose, at the right time is both the challenge and opportunity of using pharmacogenetics in drug development. This review will address these questions with several real-life examples.