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从医疗器械数据中检测安全信号的贝叶斯框架.

Jianjin Xu1, Adrijo Chakraborty1, Archie Sachdeva2

  • 1Division of Biostatistics, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.

Journal of biopharmaceutical statistics
|March 10, 2025
PubMed
概括

本研究引入了贝叶斯的框架,用于临床试验中医疗器械安全性评估. 它有效地检测不良事件差异,为传统方法提供了强大的替代方案.

关键词:
迪里克莱特过程之前的先行过程.层次化的贝叶斯分析.安全信号检测检测安全信号检测

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