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在队列和自我控制病例系列设计中比较设计和评估能力,用于授权后的疫苗安全研究

Shuntaro Sato1, Yurika Kawazoe1, Tomohiro Katsuta2

  • 1Clinical Research Center, Nagasaki University, Nagasaki, Japan.

PeerJ
|January 29, 2024
PubMed
概括

授权后安全研究 (PASS) 需要进行强大的功率分析. 队列和自我控制病例系列 (SCCS) 设计都需要大量的样本来评估疫苗的安全性,特别是对于罕见的不良事件.

关键词:
授权后的疫苗安全研究.动力分析 动力分析自主控制的案例系列设计设计.

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