基于生理药代动力学模型从体外及临床前数据对人体药代动力学预测及优化应用状况  

Current situation of prediction and optimization of human pharmacokinetics based on physiological pharmacokinetic models from in vitro and preclinical data

作　　者：杨妍妍 谢潘潘 史爱欣[1,2] YANG Yan-yan;XIE Pan-pan;SHI Ai-xin(Clinical Trial Center,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,China,Beijing 100730,China;Life Science and Biological Pharmacy Academy,Shenyang Pharmaceutical University,Shenyang 110016,Liaoning Province,China)

机构地区：[1]北京医院临床试验研究中心国家老年医学中心中国医学科学院老年医学研究院,北京100730 [2]沈阳药科大学生命科学与生物制药学院,辽宁沈阳110016

出　　处：《中国临床药理学杂志》2021年第20期2853-2856,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：生理药代动力学(PBPK)模型可通过整合药物的制剂学信息、PBPK参数和生物的解剖学参数,模拟药物在个体内的药代动力学特征,也可以将药代动力学数据进行体内外、不同种属、不同情形(年龄/疾病/用药模式)下的外推。其中,从临床前动物数据外推至人体可以更安全、更经济、更有效率地辅助临床研发的进行。本文就PBPK模型从临床前数据对人体药代动力学预测的应用现状进行阐述,并对其在创新药研发中的应用前景进行分析和探讨。Physiologically based pharmacokinetic(PBPK)model can simulate the pharmacokinetic characteristics of drugs in individuals by integrating the pharmaceutical information,physiological pharmacokinetic parameters and biological anatomical parameters,and can also carry out the pharmacokinetic data extrapolation in vivo and in vitro,in different species,and in different situations(age/disease/drug mode).Among them,extrapolation from pre-clinical animal data to humans can make clinical development safer,more economical,and more efficient.This article describes the application status of PBPK model to predict human pharmacokinetics from preclinical data,and analyzes and discusses its application prospects in innovative drugs.

关 键 词：生理药代动力学模型 临床前数据 种属外推 数据外推 人体药代动力学 

分 类 号：R95[医药卫生—药学]