一个 (不是) 新的Rx:为NAM提高质量
1Health and Environmental Sciences Institute, Washington, DC, 20005, USA.
Regulatory toxicology and pharmacology : RTP
|December 25, 2023
概括
新方法方法 (NAMs) 提供了安全评估的进步,但面临着采用挑战. 从质量改进 (QI) 运动中吸取的教训可以指导NAM的开发和实施,以便更广泛地使用.
科学领域:
- 毒理学和安全性评估
- 监管科学 监管科学
- 公共卫生 公共卫生
背景情况:
- 新方法方法 (NAM) 越来越多地用于食品,药物,消费品和化学安全评估.
- 尽管技术和立法发展,但NAM的广泛采用面临着重大挑战.
- 一种丧的感觉伴随着NAMs的快速发展和出版.
研究的目的:
- 断言在采用NAM方面面临的挑战并不是唯一的.
- 识别从质量改进 (QI) 运动中学习的机会.
- 为NAM的开发和实施提供建议.
主要方法:
- 这篇评论分析了 NAM 采用的挑战.
- 它将NAM的采用障碍与公共卫生和医疗保健质量改善 (QI) 运动中的经验进行了比较.
- 从QI中学到的经验教训被应用到NAM战略中.
主要成果:
- 在采用NAM时遇到的挑战与QI运动历史上面临的挑战有相似之处.
- 几十年的QI经验为NAMs提供了有价值的见解,无论是积极的还是消极的.
- 从QI中可以推导出特定的策略,以促进NAM集成.
结论:
- 人们认为NAM采用挑战的独特性可能被夸大了.
- 利用 QI 运动的丰富经验可以加速 NAM 的成功整合.
- 基于QI原则的有针对性的建议可以指导未来的NAM开发和政策.
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