Sex Differences in Drug Development

Blickpunkt der Mann 2008; 6 (1): 21-25

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Keywords: Geschlecht,  Pharmakologie,  gender,  pharmacology

The premise of individualized or personalized medicine is that the intervention is tailored to the individual. Individualized therapy will accommodate differences in body size, differences in metabolism and elimination, as well as differences in response. One appropriate starting point for individualized therapy is to focus on sex differences. Men and women differ in critical molecular, genetic, cellular, and physiological aspects. One important consequence of these differences is how sex influences drug disposition and impact. While, historically, women were excluded from most clinical studies, more recently there have been attempts to include them as subjects in all aspects of drug development. Additionally, more attention is being directed to sexappropriate diagnosis and treatment of disease as a component of individualized medicine. Despite this increased attention to sex differences, there remain substantial gaps in our understanding of sex differences in drug development, the focus of this review. This review was adapted from a talk presented at the Second International Congress of Gender Medicine in Vienna in 2007.