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在发育和生殖毒性研究中实施虚拟控制组的观点.

L David Wise1, Alan M Hoberman2, Christopher J Bowman3

  • 1Independent Teratologist, Retired, Philadelphia, Pennsylvania, USA.

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概括

虚拟控制组 (VCG) 可以通过使用历史控制数据 (HCD) 来减少毒理学研究中的动物使用. 在发育和生殖毒性研究中,建议采用混合方法,将VCG与并发对照组 (CCG) 结合起来.

关键词:
在DART中使用DART.关于EFDT的研究在FEED研究中,研究人员对FEED进行了研究.这是一个HCD,HCD是HCD.在PPND研究中,研究了PPND的研究.在 VC VC 中,VC 是 VC.这是VCGCG.同时控制的同时控制.历史控制 历史控制虚拟控制器 虚拟控制器

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科学领域:

  • 毒理学 毒理学 毒理学
  • 动物福利 动物福利
  • 监管科学 监管科学

背景情况:

  • 虚拟控制组 (VCG) 在2020年提出,通过利用历史控制数据 (HCD) 来减少非临床毒理学中的动物使用.
  • 越来越多的出版物强调了实施的挑战,但协调的实验室非常适合VCG采用.
  • 发育和生殖毒性研究是减少动物数量的重要领域.

研究的目的:

  • 建议在常规的良好实验室实践 (GLP) 非临床毒理学研究中实施VCG的框架.
  • 为应对与VCG实施相关的挑战和风险.
  • 支持减少在毒理学研究中的动物使用.

主要方法:

  • 在GLP研究中应用六步VCG实施框架.
  • 通过追溯和前性试验进行验证.
  • 建议采用混合方法,将并发控制组 (CCG) 与虚拟控制 (VC) 动物结合起来.

主要成果:

  • 讨论VCG实施中先前识别的风险和挑战.
  • 建议采用混合方法来缓解担忧,包括一个小的CCG与VC动物.
  • 混合方法确保了对疾病/环境变化的监测,并保护了HCD.

结论:

  • 进行协调研究的实验室应计划在动物和子的发育和生殖毒性研究中实施VCG.
  • 跨多个实验室的协调方法可以促进监管批准.
  • 及时实施VCG,特别是混合模型,可以显著减少关键毒理学研究中的动物数量.