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评估H295R类固醇生成试验数据,以获得可靠的解释.

H Tinwell1, A Karmaus2, V Gaskell3

  • 1Bayer SAS, 16 Rue Jean-Marie Leclair, 69009, Lyon, France.

Regulatory toxicology and pharmacology : RTP
|July 25, 2023
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概括

H295R类固醇生成试验可以识别影响激素合成的化学物质. 更严格的解释标准提高了数据的可靠性,减少了对内分泌干扰不必要的后续测试.

关键词:
测试性能 测试性能内分泌干扰 干扰内分泌系统在体外 (in vitro) 的情况下.经合组织经济合作与发展组织TG456类固醇的产生.

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科学领域:

  • 内分泌学 在内分泌学.
  • 毒理学 毒理学 毒理学
  • 测试开发 测试开发

背景情况:

  • H295R类固醇生成试验 (OECD TG 456) 评估了化学干扰类固醇激素合成的情况.
  • 积极的结果可能需要进行广泛的,更高层次的监管测试.
  • 利益相关者数据的汇编对于测试结果的表征至关重要.

研究的目的:

  • 编译和分析H295R测试数据,包括触发的更高层次测试.
  • 评估统计分析和解释标准对H295R结果的影响.
  • 为改进H295R数据解释和监管使用提出精细的标准.

主要方法:

  • 编制H295R参考和测试项目数据的利益相关者数据库.
  • 包括关于触发的5级生殖毒性研究的信息.
  • 对对显著性测试的分析和对补充性解释标准的应用 (例如,1.5倍变化).

主要成果:

  • 在H295R试验中,在满足质量控制验收标准方面出现了挑战.
  • 双对显著性测试导致过度敏感的积极结果,增加了试验的积极命中率.
  • 互补的解释标准显著减少了模两可的和积极的结果,提高了强有力的效应的识别.

结论:

  • 更严格的数据解释标准,如折叠变化值,可以改进H295R试验结果.
  • 改进的解释可以减少不必要的体内随访测试,正如一个案例研究所建议的那样.
  • 拟议的标准增强了H295R数据的解释,用于评估内分泌干扰的监管决策.