摘要
儿科人群的药代动力学特征特殊,药物在其体内的吸收、分布、代谢和排泄均不同于成年人。当一种药物的拟治疗疾病是典型的儿科疾病或拟治疗人群包含儿童时,应在儿童中进行药代动力学研究。本文总结了近几年国内外有关儿科人群药代动力学研究文献及指导原则,儿科人群的生理特点及其对药代动力学的影响,儿科人群药代动力学研究的适用范围,儿科人群临床试验设计以及群体药代动力学在儿科人群中的应用等进行综述。
Because of the body developmental immaturity, pediatric shows special pharmacokinetic characteristics in the body′s absorption, distribution, metabolism and excretion,which are different from adults. When a drug intended to treat disease that is a typical pediatric diseases or intended to treat population which includes children, then pharmacokinetic study of the drug should be carried out in children.This article summarizes related pediatric population pharmacokinetic study literature and guidelines of domestic and foreign in recent years,through the physiological characteristics of pediatric population and its impact on the pharmacokinetics, the scope of pediatric population pharmacokinetic study,clinical experimental design of pediatric population and the applications of population pharmacokinetics in the pediatric population to provide guidance for clinical researchers when conducting pediatric population pharmacokinetic studies and guiding the rational use of drug in children.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2014年第3期238-241,共4页
The Chinese Journal of Clinical Pharmacology
基金
国家重大新药创制科技重大专项基金资助项目(2012ZX09303014-001)
关键词
儿科人群
药代动力学
试验设计
群体药代动力学
pediatric population
pharmacokinetic
study deign
population pharmacokinetic
