深呼吸:基于证据的呼吸安全评估方法
John J Kremer1, Matt Bridgland-Taylor2, Matt Clark3
1Novartis Biomedical Research, 220 Massachusetts Avenue, Cambridge, MA 02139, USA.
概括
更新非临床呼吸道测试对于更好的临床翻译和监管审查至关重要. 建议对低风险治疗方法进行简化,并加强安全调查.
科学领域:
- 药理学 药理学是指药理学的学科.
- 毒理学 毒理学 毒理学
- 药物开发 药物开发
背景情况:
- 目前的非临床呼吸道测定需要现代化,以提高其临床相关性和成本效益.
- 国际协调会议 (ICH) S7A呼吸道检测指南可能受益于更新.
- 优化动物使用和开发成本是临床前安全测试的关键考虑因素.
研究的目的:
- 倡导现代化非临床呼吸道检测的必要性和行为.
- 提出一种简化方法来评估低风险治疗药物的呼吸安全性.
- 推研究潜在的呼吸安全危害的增强方法.
主要方法:
- 基于观点的手稿讨论当前的指导方针和潜在的改进.
- 分析非临床呼吸道试验的转化影响.
- 审查监管要求和成本优化策略.
主要成果:
- 一种现代化的方法可以提高呼吸试验对临床结果的翻译价值.
- 简化方案可能适用于预期风险最小的治疗方法.
- 对于潜在的呼吸安全问题,需要进行更严格的补充调查.
结论:
- 更新非临床呼吸道测试对于提高药物开发效率和监管合规性至关重要.
- 建议采取平衡的方法,对低风险药物采用简化方法,并对潜在危害进行强有力的测试.
- 现代化将加强呼吸安全评估的监管相关性和临床影响.
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