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Updated: Jun 14, 2025

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采用安全信号评估中的快速现实世界数据分析框架

Lu Wang1, Negar Golchin2, Stephanie von Klot3

  • 1Janssen Research and Development LLC, The Pharmaceutical Companies of Johnson & Johnson, 200 Tournament Drive, Horsham, PA, 19044, USA.

Therapeutic innovation & regulatory science
|September 6, 2024
PubMed
概括

现实世界数据 (RWD) 提供了宝贵的安全见解,但需要有效的分析. 一个新的框架有助于安全团队在监管时间表内快速提供RWD证据.

关键词:
最小的协议协议.药物监督 药物监督 药物监督快速的数据分析.现实世界数据 (RWD)安全信号评估安全信号评估超速加速 超速加速

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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