对于预测药物相互作用而言,PBPK平台资格的积极含义是:接受裂只是为了看到更大的差距!
1Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK; Certara Predictive Technologies, Sheffield, UK.
Drug metabolism and pharmacokinetics
|January 6, 2026
概括
基于生理学的药理动力学 (PBPK) 建模对于药物相互作用 (DDI) 评估至关重要. 最近的监管接受和协调努力表明,全球对这些先进技术达成共识.
科学领域:
- 药理动力学和药物新陈代谢
- 计算生物学和生物信息学
- 监管科学 监管科学
背景情况:
- 基于生理学的药理动力学 (PBPK) 从学术概念演变为评估药物相互作用 (DDI) 的工业和监管必要性.
- 监管机构采用PBPK进行DDI评估一直是不一致的,原因是不同的运营结构,劳动力能力和研究能力.
- 尽管存在差异,但正在出现越来越多的全球共识,例如EMA对DDI的PBPK评估平台的资格认证.
研究的目的:
- 审查PBPK建模中用于DDI评估和管理的最新趋势和关键参考.
- 提供对药物开发中PBPK应用的历史进展和未来方向的见解.
- 突出最近的监管发展和国际协调努力的重要性.
主要方法:
- 迷你综述综合关键文献和监管文件.
- 分析PBPK应用程序从学术界到监管要求的演变.
- 对影响监管采用和协调PBPK对DDI的影响因素的审查.
主要成果:
- 越来越多地认为PBPK建模对于DDI评估至关重要,朝着监管要求迈进.
- 由于内部因素,监管机构对PBPK的采用率和方法各不相同.
- 欧洲药物管理局对PBPK平台的资格认证和ICH M12指南代表了朝着全球协调迈出的重要一步.
结论:
- 最近的监管里程碑表明,对PBPK技术用于DDI评估的标准化使用的趋同.
- 协调努力,包括ICH M12指南,对于PBPK的全球一致应用至关重要.
- 未来可能会扩大PBPK建模的应用范围,超出目前的DDI评估范围.
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