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Updated: May 28, 2025

An R-Based Landscape Validation of a Competing Risk Model
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在临床试验中基于风险的质量管理 (RBQM) 的采用成熟度模型

Maria Florez1, Abigail Dirks2, Linda Sullivan2

  • 1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. maria.florez@tufts.edu.

Therapeutic innovation & regulatory science
|February 14, 2025
PubMed
概括

基于风险的质量管理 (RBQM) 的采用在大型制药公司中最高,创新者和早期采用者实施了大多数组件. 需要进一步的研究来了解采用途径和更广泛实施的障碍.

关键词:
收养 成熟期 收养 成熟期临床试验 临床试验对于质量因素至关重要的质量因素.创新 采用 创新 采用协议复杂性 协议的复杂性协议设计 协议设计通过设计的质量.基于风险的监测 基于风险的监测基于风险的质量管理

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