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在临床前试验中基于模型的评估和翻译心血管安全的教程
Victoria Kulesh1,2, Igor Vasyutin1, Alina Volkova1,3
1Modeling & Simulation Decisions FZ-LLC, Dubai, United Arab Emirates.
CPT: pharmacometrics & systems pharmacology
|November 11, 2023
概括
本研究提出了一种工作流程,用于分析药物对动物心血管系统的影响,使用血液动力学数据. 它解决了定量评估的挑战,帮助开发更安全的药物和人类翻译.
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
- 生物医学工程 生物医学工程
背景情况:
- 心血管安全评估在药物发现中至关重要,以改进治疗指数.
- 预临床预测意外的心血管影响对于安全的首次给人剂量至关重要.
- 目前的指导方针要求通过遥测进行非临床心血管安全评估,但定量评估仅限于心电图,而不是血液动力学.
研究的目的:
- 为分析血液动力学参数的非临床心血管安全数据提供全面的工作流.
- 解决动物血液动力安全信号的定量评估中的挑战.
- 为了促进动物心血管安全研究结果的无和高效转化为人类预测.
主要方法:
- 利用基于模型的方法,包括药物动力学-毒力学分析和系统药理学建模.
- 开发了一种序列工作流程,用于分析血液动力学参数上的遥测数据.
- 包含一个可重复的示例来展示拟议的分析方法.
主要成果:
- 在临床前研究中建立了一种系统方法来评估药物诱导的血液动力学变化.
- 确定并提出解决动物心血管遥测数据分析中常见挑战的解决方案.
- 证明了基于模型的分析对评估心血管安全信号的有用性.
结论:
- 开发的工作流程增强了非临床心血管安全研究中血液动力学参数的定量评估.
- 这种方法支持更准确地预测与药物有关的心血管风险.
- 促进了临床前发现的改进转化为临床安全评估,优化药物开发.
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