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在临床试验中采用基于风险的质量管理的全面评估

Abigail Dirks1, Maria Florez2, Francois Torche3

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

Therapeutic innovation & regulatory science
|February 17, 2024
PubMed
概括

基于风险的质量管理 (RBQM) 通过关注关键数据风险,提高临床试验效率. 尽管有监管鼓励,但采用面临诸如知识缺乏和变化管理不良等障碍,阻碍了其广泛实施.

关键词:
从设计开始的质量.基于风险的监测是基于风险的监测.基于风险的质量管理.

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