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证明基于体内代谢基因组的化学分类的可靠性:朝着最佳实践迈进

Mark R Viant¹, E Amstalden², T Athersuch³

¹Phenome Centre Birmingham, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. m.viant@bham.ac.uk.

Archives of toxicology

|February 18, 2024

概括

当数据质量得到保证时,代谢学可靠地将化学物质分为类别,即使使用各种方法. 这种方法支持可靠的化学安全评估和监管接受.

科学领域:

毒理学和化学安全
代谢学代谢学代谢学
监管科学监管科学

背景情况:

化学品分组/交叉阅读对于监管数据缺口至关重要,但由于缺乏充分的理由,通常会失败.
代谢学提供了一个强大的替代方案,通过识别化学分类的共享分子效应.
国际认可要求证明高可靠性,并制定最佳实践指南,以对代谢组分组合的代谢组分组合.

研究的目的:

为了评估化学分组的代谢组的实验室间可重复性.
制定最佳实践指南,用于化学分类中的代谢学.
评估代谢学对化学组的监管接受的可靠性.

主要方法:

一个盲目的,多实验室环试验 (MATCHING) 涉及六个合作伙伴.
在老鼠身上测试了八种不同的物质,用参与者喜欢的LC-MS代谢流程分析了血样本.
数据处理,质量评估,统计分析和分组结果向监管机构报告.

主要成果:

六个合作伙伴中的五个成功地将八种物质分为三类,对雄性和雌性大鼠来说都是如此.
尽管使用了多种不同的代谢学工作流程,但仍取得了成功的分组.
一个合作伙伴由于通过质量控制发现的高技术差异而失败.

结论:

代谢学是一种可靠的化学分组方法,在不同实验室和工作流程中表现出一致性.
严格的数据质量评估对于使用代谢学成功进行化学分组至关重要.
建议采用国际质量控制指南,以提高基于代谢学化学物质分组的接受度.

关键词:

指导指导的指导.代谢学代谢学代谢学经合组织经合组织的经合组织组织的经合组织组织的经合组织的经合组织的经合组织的经合组织的经合组织.可复制性可复制性标准化的标准化工作.验证验证验证验证

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