Esposito Simone, Cebrián David
Integrated Drug Discovery, Selvita SA, Podole 79, 30-394 Kraków, Poland.
Drug Discov Today. 2025 Aug;30(8):104427. doi: 10.1016/j.drudis.2025.104427. Epub 2025 Jul 8.
The use of translational physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling has become a standard practice in drug discovery, providing advanced data integration accounting for species-specific physiology and target pharmacology. This paper provides a preclinical contract research organization (CRO) perspective on the applications, benefits, and challenges of translational PBPK/PD modeling approaches in integrated drug discovery (IDD) collaborations. We also describe how PBPK/PD approaches have impacted the role of the drug metabolism and pharmacokinetics project representative (DPR) within CROs. We propose that adopting translational PBPK/PD approaches enhances the sponsor-CRO IDD partnership by fostering data-driven project decision-making and optimizing the use of resources.
基于生理学的药代动力学和药效学（PBPK/PD）转化模型的应用已成为药物研发中的标准做法，可提供考虑物种特异性生理学和靶点药理学的先进数据整合。本文从临床前合同研究组织（CRO）的角度，探讨了PBPK/PD转化模型方法在整合药物研发（IDD）合作中的应用、益处和挑战。我们还描述了PBPK/PD方法如何影响了CRO中药代代谢与药代动力学项目代表（DPR）的角色。我们认为，采用PBPK/PD转化方法可通过促进数据驱动的项目决策和优化资源利用，加强申办方与CRO的IDD合作关系。
