Abstract

Biological differences between men and women are historically overlooked in medication development and clinical trials. Despite a call to action by US National Institutes of Health (NIH) in 1993 for inclusion of women in biomedical research, experimental design in cellular, animal, and phase 1 studies continues to neglect sex-based analyses and considerations. Key sex-specific pharmacodynamic differences include lower glomerular filtration rate, reduced gastric motility, increased gastric pH, and reduced liver and lung mass in women than in men.

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