Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop

Issuing agencies

Abstract

The Food and Drug Administration (FDA) Office of Women's Health and Office of Clinical Pharmacology is announcing the following public workshop: "Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research." The purpose of the public workshop is to discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop. Presentations will discuss whether changes in drug absorption, distribution, metabolism, and elimination, if any, could be affected by hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes). The discussion is further intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. Speakers will highlight areas with the greatest need for further research and exploration.