• Clin. Pharmacol. Ther. · Mar 2015

    Review

    Racial/ethnic differences in drug disposition and response: review of recently approved drugs.

    • A Ramamoorthy, M A Pacanowski, J Bull, and L Zhang.
    • Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
    • Clin. Pharmacol. Ther. 2015 Mar 1; 97 (3): 263-73.

    AbstractRace and ethnicity can contribute to interindividual differences in drug exposure and/or response, which may alter risk-benefit in certain populations. Approximately one-fifth of new drugs approved in the past 6 years demonstrated differences in exposure and/or response across racial/ethnic groups, translating to population-specific prescribing recommendations in a few cases. When data from diverse populations were lacking, additional postmarketing studies were recommended. In this review we highlight several cases where race/ethnicity was central to regulatory decision-making. © 2015 American Society for Clinical Pharmacology and Therapeutics.

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