评估药物发现和开发中的DDI风险:方法,挑战和趋势
Hong-Can Ren1, Chunyong He2, Hong Wan3
1Department of DMPK, Genescience Pharmaceuticals Co., Ltd. Research and Development, Shanghai, China.
Expert opinion on drug metabolism & toxicology
|December 18, 2025
概括
药物相互作用 (DDI) 既带来风险又带来机遇. 使用人工智能和PBPK建模等先进工具的战略管理对于药物开发至关重要,特别是在瘤学中.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 计算生物学 计算生物学
背景情况:
- 药物相互作用 (DDI) 显著影响药物的有效性和安全性,既带来风险,也带来治疗机会.
- 管理DDI在药物开发中至关重要,特别是在瘤学等高度未满足需求的领域.
研究的目的:
- 审查DDI风险评估方法,临床前和临床相关性方面的挑战,以及预测工具的进展.
- 突出DDI预测方面的创新,包括人工智能 (AI) 和内源生物标志物.
主要方法:
- 在PubMed中进行全面的文献搜索,截至2025年10月25日.
- 探索基于生理学的药理动力学 (PBPK) 建模及其在DDI评估中的作用.
- 对AI和基于生物标志物的方法进行DDI风险预测的审查.
主要成果:
- 基于生理学的药理动力学 (PBPK) 建模,结合药理动力学 (PD) 和毒性 (Tox) 数据,是评估临床影响的关键.
- 人工智能 (AI) 和内源生物标志物为DDI风险预测提供了新的,非侵入性的方法.
- 将计算,体外和临床数据集成到积极的框架中,可以持续预测DDI风险和机会.
结论:
- 整合多方面的数据的积极战略对于在整个药物生命周期中管理DDI的双重性质至关重要.
- 预测方法的严格基准测试对于弥合翻译差距,提高研发效率和推进候选药物至关重要.
- 先进的预测工具和综合数据框架是优化药物开发和减轻DDI相关风险的关键.
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