In medicine, the term drug refers to any substance able to prevent or cure diseases. The drug development is a lengthy, complex, and costly process, with a high degree of uncertainty; during 15 years therapeutic development pipeline of 10,000 starting compounds, just one drug is approved. This high rate of failure could reside in the use of in vitro and in vivo models that only partially recapitulate a disorder, but some pitfalls can be also linked to gender. Indeed, sex differences in drug absorption and efficacy have been largely described. For these reasons, in ’90s, the FDA issued the gender differences in drug guidelines. Currently, drugs have to be studied on subjects of both sexes before their final approval. In Italy, AIFA has introduced additional regulations during the process of drug authorization, concerning the amount of female population proportion involved in clinical trials, and the need of sub-analysis by gender.
Keywords: Drug; gender differences; preclinical studies; clinical studies; pharmacovigilance; gender sub-analysis.