OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
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DOI：
10.1093/jamia/ocv153
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发表时间：
2016-05
期刊：
影响因子：
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通讯作者：
Bright RA
中科院分区：
文献类型：
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作者：
Kass-Hout TA;Xu Z;Mohebbi M;Nelsen H;Baker A;Levine J;Johanson E;Bright RA
目的OpenFDA的目标是通过应用程序编程接口(API)协调不同FDA数据集的数据，方便开发人员、研究人员和公众访问和使用重要的食品和药物管理局大型公共数据集。材料和方法使用部署在FDA新的公共云计算基础设施上的尖端技术，OpenFDA提供更容易、更快(每个进程每秒超过300个请求)和更好地访问FDA数据集的开放数据；开放源代码和文档共享在GitHub上，用于开放社区贡献的例子、应用程序和想法；以及可用于其他公共卫生大数据挑战的基础设施。结果自2014年6月2日推出以来，OpenFDA已经开发了四个用于药品和设备不良事件、所有FDA监管产品的召回信息和药品标签的API。已经有2000多万个API调用(超过一半来自美国以外)，6000个注册用户，2万个连接的互联网协议地址，以及数十个新的软件(移动或网络)应用程序开发。一项案例研究展示了使用Open FDA数据来了解药物与不良事件的明显关联。结论：通过更容易、更快地访问这些数据集，世界各地的消费者可以更多地了解FDA监管的产品。
Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Materials and Methods Using cutting-edge technologies deployed on FDA’s new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Results Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products.