Ramamoorthy A, Pacanowski M A, Bull J, Zhang L
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;97(3):263-73. doi: 10.1002/cpt.61. Epub 2015 Jan 20.
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.
种族和族裔可能导致个体在药物暴露和/或反应方面存在差异,这可能会改变某些人群的风险效益。在过去6年获批的新药中,约五分之一显示出不同种族/族裔群体在暴露和/或反应方面存在差异,在少数情况下转化为针对特定人群的用药建议。当缺乏来自不同人群的数据时,建议开展额外的上市后研究。在本综述中,我们重点介绍了几例种族/族裔在监管决策中起核心作用的案例。