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

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Medicines For Women

Abstract

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.

The views expressed are those of the authors and do not necessarily reflect official policy of the US FDA. No official endorsement by the US FDA is intended or should be inferred.

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Authors and Affiliations

  1. Office of Women’s Health, Office of the Commissioner, Food and Drug Administration, Building 32, Room 2312 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    Emmanuel O. Fadiran

  2. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA

    Lei Zhang

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  1. Emmanuel O. Fadiran
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Correspondence to Emmanuel O. Fadiran .

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  1. Dean’s Department, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand

    Mira Harrison-Woolrych

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Fadiran, E.O., Zhang, L. (2015). Effects of Sex Differences in the Pharmacokinetics of Drugs and Their Impact on the Safety of Medicines in Women. In: Harrison-Woolrych, M. (eds) Medicines For Women. Adis, Cham. https://doi.org/10.1007/978-3-319-12406-3_2

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