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对风险最小化/减轻的监管指南和报告建议的比较 旨在制药风险最小化评估研究的检查清单

Sonia Guleria1, Emily Brouwer2, David A Brown2

  • 1Epidemiology & Real-World Science, Parexel, Gothenburg, Sweden.

British journal of clinical pharmacology
|September 19, 2024
PubMed
概括

评估风险最小化措施 (RMM) 有效性的监管指南在全球范围内各不相同. 大多数国家缺乏具体的RMM指导,现有的建议与RIMES检查清单质量标准的一致性有限.

关键词:
欧洲药品监督管理局 (EMA) 是一个.美国食品药品监督管理局 FDA FDA检查清单 检查清单 检查清单在授权后进行的研究.衡量风险的措施 衡量风险的措施风险最小化 降低风险最小化

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