Sex and gender effects: relevance for drug development and precision pharmacology

The incidence, clinical manifestations, therapeutic responses, and side effects of various pathological conditions can vary significantly between sexes, underscoring the need for sex-specific approaches to optimize diagnostic and therapeutic strategies. This course aims to provide a foundational understanding of the molecular, cellular, and biological mechanisms underlying sex-related differences in physiopathology and drug responses, addressing gaps in knowledge about the influence of sex and gender on health and their relevance for drug development and precision pharmacology. The course is structured into three parts: 1) The first part explores sex- and gender-related differences in key disease areas and the importance of integrating sex as a biological variable (SABV) in basic, preclinical, clinical, and population health studies; 2) The second part focuses on applying the NIH SABV policy in research design, analysis, and reporting; 3) The third part delves into sex and gender differences in pharmacokinetics, pharmacodynamics, and drug adverse effects.