儿童生理药动学模型及其在儿科用药研究中的应用进展  

Pediatric physiologically based pharmacokinetic model and its applications in pediatric drug research

作　　者：余果 黎国富[2] 郑青山[2] 王大新 

机构地区：[1]江苏省苏北人民医院扬州大学临床医学院医学实验研究中心,江苏扬州225001 [2]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国新药与临床杂志》2014年第6期414-420,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家科技支撑计划项目(2008BAI51B03);国家973计划项目(2007CB936104);上海市中医药事业发展三年行动计划项目(ZYSNXD-CC-LCPJ);江苏省医学领军人才与创新团队建设项目(LJ201159)

摘　　要：在儿科用药研究中,儿童生理药动学(PBPK)模型已成为确定首次儿童用药剂量和指导儿童临床试验设计的一个重要方法。本文通过比较PBPK模型和房室模型,并结合既往的经验,重点从发育生理学和细胞色素P450酶的个体发生学等方面阐述儿童PBPK模型的特点,介绍儿童PBPK模型的建模策略、误区及注意事项,同时结合最新的文献实例和FDA审评观点,对其在儿科用药研究方面的前景进行了分析和探讨。In pediatric investigation plans, pediatric physiologically based pharmacokinetic （PBPK） modeling has been recognized as a critical approach for the dose selection of ＂first- in- children＂ and the optimization of pediatric clinical trial. In this review, the capabilities of PBPK models were compared with those of compartmental models, and the special issues in pediatric PBPK models from perspectives on developmental physiology and ontogeny of cytochrome P450 enzymes were interpreted. Moreover, a strategy for pediatric PBPK modeling was proposed. Finally, literature cases from academy, industry, and FDA to exemplify the role of pediatric PBPK models in pediatric investigation plans were analyzed.

关 键 词：药动学 儿童 临床试验 生理药动学模型 

分 类 号：R969[医药卫生—药理学]