Effects of Sex Differences in the Pharmacokinetics of Drugs and Their Impact on the Safety of Medicines in Women

  • Emmanuel O. Fadiran
  • Lei Zhang


Inclusion of women in clinical trials and analysis of clinical trial data for sex/gender effects have been an integral component of the US FDA’s consideration for approval of pharmaceutical products since the mid-1980s (1993). The study of sex differences is now a routine component of drug development because of existing data in drug exposure and response differences between men and women and the need to understand such differences for proper dosing. The resulting expanding knowledge of sex differences in the exposure and responses to drugs has led to a better understanding of the mechanisms contributing to these differences and improved pharmacotherapy for men and women.


Lower Glomerular Filtration Rate Ceftaroline Fosamil Body Weight Difference Influence Drug Disposition Olanzapine Clearance 
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© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Office of Women’s Health, Office of the Commissioner, Food and Drug AdministrationSilver SpringUSA
  2. 2.Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA

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