ICH Q3C修订的第一部分:对第1类残留溶剂的重新评估
1Xiphora Biopharma Consulting, 9 Richmond Apartments, Redland Court Road, Bristol, BS67BG, UK.
Regulatory toxicology and pharmacology : RTP
|October 25, 2025
概括
根据新的数据,需要更新ICH Q3C Class 1级溶剂限值. 自1997年以来不变的当前允许的每日暴露限值可能不反映这些残留溶剂的当前毒理学理解.
科学领域:
- 制药化学 制药化学 制药化学
- 毒理学 毒理学 毒理学
- 监管科学 监管科学
背景情况:
- ICH Q3C指南将五种残留溶剂归类为第一类 ("应避免").
- 自1997年提出以来,这些溶剂的允许每日暴露 (PDE) 极限没有经过修订.
- 最近的毒理学数据和专家评估要求重新评估这些极限值.
研究的目的:
- 对ICH Q3C Class 1残留溶剂的当前毒理学数据进行审查.
- 评估现有的PDE极限的适用性.
- 建议对分类和可接受摄入量限制进行可能的修订.
主要方法:
- 关于第一类溶剂的毒理学研究的综合文献综述.
- 对有关溶剂致癌性和致病性专家评估的分析.
- 对变种致癌物质的ICH M7(R2) 准则的适用性评估.
主要成果:
- 有证据表明,除二烯外,所有1类溶剂的PDE限值应该修订.
- 两种被确定为潜在的致癌物质的1类溶剂,适用于根据ICH M7 (R2) 标准确定可接受摄入量 (AI) 限值.
- 对于基于度的限值,每日10克药物物质剂量的假设受到质疑.
结论:
- 由于新的科学信息,目前的ICH Q3C Class 1溶剂限值需要重新评估.
- 对于特定的第1类溶剂,建议对PDE进行修订并考虑AI限值.
- 确定基于度的限制值的方法需要进一步审查.
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