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在安全信号评估中利用现实世界的数据

Vaishali Patadia1, Katrin Manlik2, Geoffrey Gipson3

  • 1Amgen, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. vpatadia@amgen.com.

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

生物制药公司越来越多地使用现实世界数据 (RWD) 来评估安全信号. 虽然有价值,但数据访问和监管接受方面的挑战需要解决,以便更广泛地采用快速RWD分析.

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.现实世界的数据数据.安全信号评估安全信号评估超速加速 超速加速

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