The significance of sex and gender in clinical pharmacokinetics

Abstract

The consequences of the historical exclusion of cisgender women and pregnant people from pharmacological clinical trials have resulted in a dangerously low quality of care for these populations. Analyzing and interpreting significant sex- and gender-related differences in drug absorption, distribution, metabolism, and excretion are critical for adjusting dosing regimens and therapeutic drug monitoring. A deep understanding of the impact of these differences is required for practitioners and clinical researchers. This review summarizes the physiological differences between the sexes as they relate to cardiovascular, respiratory, gastrointestinal, and renal variations. A direct examination of the possible effects of these difference on the pharmacokinetics of drugs critically highlights the current knowledge gap. The importance of including all sexes in clinical trials and pharmacokinetic studies is emphasized in this review. Current and future scientists should strive toward reducing health care disparities based on sex and gender in their studies, incorporating sex and gender-specific analysis whenever possible.