检测,监测和缓解药物诱导的毒性:一个务实的方法
Nicola Antognini1, Ronald Portman2, Victor Dong2
1Novartis Pharma AG, Basel, Switzerland.
Therapeutic innovation & regulatory science
|December 19, 2023
概括
在临床试验中识别药物诱导的毒性 (DIN) 是具有挑战性的,因为功能各异. 本指南旨在改善DIN的早期检测和管理,保护参与者的脏健康.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
背景情况:
- 脏对于药物排泄至关重要,使它们容易受到药物诱导的毒性 (DIN).
- 以前存在的功能障碍可能会使急性DIN的识别和补偿变得复杂.
- 目前用于检测损伤的方法可能不足以用于早期DIN诊断.
研究的目的:
- 为药物开发中早期识别和管理DIN提供基于证据的指导.
- 为了最大限度地减少DIN对临床试验参与者的功能的影响.
- 为了促进脏安全数据的收集,用于风险分析和降低风险.
主要方法:
- 审查关于脏生理学,病理学和DIN的当前文献.
- 分析在不同患者群体中识别DIN的挑战.
- 关于早期检测和管理DIN.的战略建议.
主要成果:
- 由于基线功能变化,早期识别DIN往往很困难.
- 需要新的生物标志物来更准确和及时诊断损伤.
- 在药物开发过程中,对管理DIN的务实方法至关重要.
结论:
- 在药物开发中,早期发现和管理DIN至关重要.
- 改进的诊断工具和支持性指导可以保护试验参与者的功能.
- 有效的DIN管理支持了强大的脏安全评估.
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