生理药动学模型的研究与应用进展

Research Progress and Application of Physiologically-based Pharmacokinetic Model

生理药动学(PBPK)模型可以利用临床前数据预测药物在人体内的药动学行为,还可以探讨各种生理参数,如年龄、种族或疾病状况对人体药动学的影响,从而指导用药剂量和给药方案,进行药物相互作用的风险评估。本文简要介绍了PBPK模型的概念、建模方法和常用软件,以及在指导新药研发、毒理学和风险评估、评价药物-药物相互作用、药品监管领域等方面的应用进展,以期了解候选药物的药代动力学,为提高药物研发效率提供方法。

Physiologically based pharmacokinetics(PBPK)model can take advantage of the preclinical data to predict the pharmacokinetic behavior of drug in the body,can also study various physiological parameters,such as age,race,or disease condition influence on human body pharmacokinetics,thus guiding the dosage and dosage regimen,assessing the risk of drug interactions.This article briefly introduces the concept,modeling method and common software of PBPK model,as well as the application progress in guiding new drug development,toxicology and risk assessment,drug interaction evaluation and drug regulation,so as to understand the pharmacokinetics of drug candidates and provide methods for improving drug development efficiency.