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信号管理和降低风险的策略:对obinutuzumab和非开放传播的血管内凝血的案例研究

Giulia Valdiserra1, Nadia Mores2, Rosalba Elisabetta Rocchi3

  • 1Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Frontiers in drug safety and regulation
|September 22, 2025
PubMed
概括

意大利监管机构发现了一种潜在的安全信号,该信号将奥比努图祖马布与非开放的扩散性血管内凝血 (DIC) 联系起来. 该信号得到了验证和确认,导致药物更新.

关键词:
扩散的血管内凝血.这就是Obinutuzumab.降低风险最小化 降低风险最小化信号分析和优先考虑.信号评估 信号评估 信号评估信号确认信号的确认.信号检测 信号检测 信号检测信号验证 信号验证

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