title: Sex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics.
abstract: The Food and Drug Administration (FDA) reviewed 300 new drug applications between 1995 and 2000. Of the 163 that included a sex analysis, 11 drugs showed a >40% difference in pharmacokinetics between males and females, which was listed on the product label, yet no dosing recommendations were made based on sex. Female sex has been shown to be a risk factor for clinically relevant adverse drug reactions. Would simply dosing females based on their different pharmacokinetics decrease the incidence of adverse events? The answer is not known. Sex-dependent pharmacodynamic effects have been identified. The role of pharmacokinetics vs. pharmacodynamics is unclear, as is the impact of pharmacogenetics on both. This review highlights a few specific examples in each area in which sex differences in pharmacokinetics and pharmacodynamics are important and provides recommendations for additional needed research.
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, Washington, USA. gaila@u.washington.edu
authors.forename: Gail D
authors.initials: GD
authors.lastname: Anderson
mesh_terms: D001682:Biological Availability; D001692:Biological Transport; D001711:Biotransformation; D004305:Dose-Response Relationship, Drug; D004333:Drug Administration Routes; D016503:Drug Delivery Systems; D011307:Drug Prescriptions / Q000592:standards; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008657:Metabolic Clearance Rate; D010597:Pharmacogenetics; D010599:Pharmacokinetics; D044469:Racial Groups / Q000235:genetics; D012727:Sex Characteristics; D045506:Therapeutic Uses; D014018:Tissue Distribution; D014481:United States; D016387:Women's Health
chemical_list: D045506:Therapeutic Uses