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journal article Jan 20, 2015

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

A Ramamoorthy MA Pacanowski J Bull
Clinical Pharmacology & Therapeutics Vol. 97 No. 3 pp. 263-273 · Wiley
View at Publisher Save 10.1002/cpt.61
Abstract
Race 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.
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Metrics
303
Citations
62
References
Details
Published
Jan 20, 2015
Vol/Issue
97(3)
Pages
263-273
License
View
Authors
A
A Ramamoorthy

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

M
MA Pacanowski

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

J
J Bull

Office of Minority Health, Office of the Commissioner, US Food and Drug Administration Silver Spring Maryland USA

Cite This Article
A Ramamoorthy, MA Pacanowski, J Bull (2015). Racial/ethnic differences in drug disposition and response: Review of recently approved drugs. Clinical Pharmacology &amp; Therapeutics, 97(3), 263-273. https://doi.org/10.1002/cpt.61
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