下一代药物安全科学：结合检测、证实和验证以发现新的药物作用和药物相互作用。
The Next Generation of Drug Safety Science: Coupling Detection, Corroboration, and Validation to Discover Novel Drug Effects and Drug-Drug Interactions.
机构信息
Department of Biomedical Informatics, Columbia University, New York, New York, USA.
Department of Systems Biology, Columbia University, New York, New York, USA.
出版信息
Clin Pharmacol Ther. 2018 Feb;103(2):177-179. doi: 10.1002/cpt.949.
Abstract
Rare adverse drug reactions and drug-drug interactions (DDIs) are difficult to detect in randomized trials and impossible to prove using observational studies. We must ascribe to a new way of conducting research that has the efficiency of a retrospective analysis and the rigor of a prospective trial. This can be achieved by integrating observational data from humans with laboratory experiments in model systems. The former establishes clinical significance and the latter supports causality.
摘要
罕见的药物不良反应和药物-药物相互作用（DDI）很难在随机试验中检测到，也不可能通过观察性研究来证明。我们必须采用一种新的研究方法，这种方法既有回顾性分析的效率，又有前瞻性试验的严谨性。这可以通过将来自人类的观察性数据与模型系统中的实验室实验相结合来实现。前者确定了临床意义，后者支持了因果关系。
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