Pharmacogenetics and personalized medicine : does gender have a role?

The study of the role of genetic polymorphisms in drug responses, is now a firmly established field of pharmacology research. It has robust applications in predicting drug effect, and therefore contributes to the process of optimum selection of drug and dose for specific patients. Since the last 10 years, the FDA as well as the EMA have set up their own pharmacogenomics advisory groups, and have flagged an increasing number of medicinal products with specific genotyping recommendations in order to reap their greatest benefit. The contribution of gender to therapeutic outcomes has long been recognised, but recent research suggests that gender influence may not only occur via well recognised hormonal pathways, but also via direct non-hormone-mediated mechanisms. This influence may confound pharmacogenetic predictors, and gender stratification may therefore be an important consideration in pharmacogenetic-based drug trials.peer-reviewe