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Published Online: 2 February 2005

Sex and Racial Differences in Pharmacological Response: Where Is the Evidence? Pharmacogenetics, Pharmacokinetics, and Pharmacodynamics

Publication: Journal of Women's Health
Volume 14, Issue Number 1


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.

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cover image Journal of Women's Health
Journal of Women's Health
Volume 14Issue Number 1January/February 2005
Pages: 19 - 29
PubMed: 15692274


Published online: 2 February 2005
Published in print: January/February 2005


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Gail D. Anderson
Department of Pharmacy, University of Washington, Seattle, Washington.

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