监测标签外使用药物的安全性。
Monitoring the safety of medicines used off-label.
机构信息
Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
Clin Pharmacol Ther. 2012 May;91(5):787-95. doi: 10.1038/clpt.2012.24.
PMID:22472983
Abstract
Off-label use of medicines is common. Because many off-label uses have not been carefully studied, it is important that postmarketing drug safety systems be able to identify, assess, and monitor adverse events that occur in the off-label setting. The full range of postmarketing surveillance and analysis tools can be utilized to study the adverse effects of medicines used off-label.
摘要
药品的标签外使用很常见。由于许多标签外使用并未经过仔细研究，因此重要的是，上市后药物安全系统能够识别、评估和监测在标签外使用情况下发生的不良事件。可以利用全方位的上市后监测和分析工具来研究标签外使用的药品的不良反应。
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