title: Racial/ethnic differences in drug disposition and response: review of recently approved drugs.
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.
authors: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: A
authors: A
authors: Ramamoorthy
authors: M A
authors: MA
authors: Pacanowski
authors: J
authors: J
authors: Bull
authors: L
authors: L
authors: Zhang
mesh_terms: D017277:Drug Approval; D004348:Drug Labeling / Q000639:trends; D005006:Ethnicity; D006801:Humans; D010597:Pharmacogenetics; D055553:Prescription Drugs / Q000493:pharmacokinetics* / Q000494:pharmacology* / Q000627:therapeutic use; D044469:Racial Groups
chemical_list: D055553:Prescription Drugs