期刊
JOURNAL OF WOMENS HEALTH
卷 14, 期 1, 页码 19-29出版社
MARY ANN LIEBERT, INC
DOI: 10.1089/jwh.2005.14.19
关键词
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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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