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Journal of women's health · Jan 2005
ReviewSex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics.
- Gail D Anderson.
- Department of Pharmacy, University of Washington, Seattle, Washington, USA. gaila@u.washington.edu
- J Womens Health (Larchmt). 2005 Jan 1;14(1):19-29.
AbstractThe 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.
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