关于在非临床毒性研究中使用虚拟控制组的STP市政厅讨论
Kirstin Barnhart1, Brad Bolon2, Laura Boone3
1MBrace Therapeutics, San Diego, California, USA.
Toxicologic pathology
|November 18, 2025
概括
在非临床毒性测试中,虚拟控制组 (VCG) 具有减少动物使用的潜力,但需要仔细考虑毒理病理. 同时控制组 (CCG) 对于生成可靠的VCG历史控制数据至关重要.
科学领域:
- 毒理学病理学 毒理学病理学
- 非临床毒性测试试验 临床毒性测试
- 药物开发 药物开发
背景情况:
- 毒理病理学会 (STP) 召开会议,讨论非临床毒性测试中的虚拟控制组 (VCG).
- 各个组织正在探索VCG,以减少在产品开发中使用动物.
- 现有的VCG文献往往缺乏毒理病理学的角度.
研究的目的:
- 从毒理病理学的角度评估VCG在非临床毒性测试中的作用和局限性.
- 讨论从并发控制组 (CCG) 转向VCG的监管接受的影响.
- 确定减少动物在毒性研究中的使用的替代策略.
主要方法:
- 在2025年STP市政厅会议上,在毒理学病理学家之间进行讨论和达成共识.
- 对VCG在非临床毒性测试中的当前文献的审查.
- 考虑VCG和历史控制数据 (HCD) 之间的关系.
主要成果:
- 同时控制组 (CCG) 对于生成VCG所需的历史控制数据 (HCD) 至关重要.
- VCG的适用性取决于上下文,更适合于具有明显测试文章 (TA) 相关影响的研究.
- 监管机构的接受是VCG广泛采用的一个关键挑战.
- 减少动物使用的替代方法包括研究设计修改和监管协议.
结论:
- 毒理学病理学家必须积极为VCG辩论提供他们的专业知识.
- 为了更广泛的科学理解,需要从病理学的角度清楚地沟通VCG的机会和挑战.
- 减少动物使用与毒性数据的完整性之间的平衡至关重要.
关键词:
同时的对照组是同步的对照组.历史控制数据 历史控制数据混合控制组是一个混合控制组.非临床毒性测试是指非临床毒性测试.安全评估安全评估的安全评估.合成对照组是一个合成对照组.虚拟控制组是一个虚拟的控制组.更多相关视频
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