This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and prod...This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and productivity of pediatric trials.The pharmacokinetics(PK)and pharmacodynamics(PD)of drugs are often different between adult and pediatric populations which necessitate specific studies in children.The aims of this review are to discuss a number of recent methodological developments of modeling and simulation that facilitate the evaluation of drugs in pediatrics.Specific focus has been placed on addressing the key issues of PK/PD scaling,sparse sampling,colinearity,covariate evaluation,dose optimization for trial design and label,modeling strategies and validation approaches.The features and potential advantages of Bayesian hierarchical model,physiology-based PK models,and K-PD models are also presented.展开更多
自从美国FDA（2004年）提出了＂基于模型的药物研发（Model Based Drug Development,MBDD）＂模式,定量药理学在全球范围内成为一个热门学科,MBDD已经列入中国＂十二五＂国家科技重大专项研究。中国药理学会数学药理专业委员会分别于200...自从美国FDA（2004年）提出了＂基于模型的药物研发（Model Based Drug Development,MBDD）＂模式,定量药理学在全球范围内成为一个热门学科,MBDD已经列入中国＂十二五＂国家科技重大专项研究。中国药理学会数学药理专业委员会分别于2007年和2010年在南京和厦门成功举办了两届＂定量药理学与新药评价国际学术会议＂（International Sympo-siumof Quantitative Pharmacologyin Drug Development and Regulation,ISQP）,吸引了国内外众多学者参加。为促进我国定量药理学的发展,增进国内外交流,展开更多
文摘This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and productivity of pediatric trials.The pharmacokinetics(PK)and pharmacodynamics(PD)of drugs are often different between adult and pediatric populations which necessitate specific studies in children.The aims of this review are to discuss a number of recent methodological developments of modeling and simulation that facilitate the evaluation of drugs in pediatrics.Specific focus has been placed on addressing the key issues of PK/PD scaling,sparse sampling,colinearity,covariate evaluation,dose optimization for trial design and label,modeling strategies and validation approaches.The features and potential advantages of Bayesian hierarchical model,physiology-based PK models,and K-PD models are also presented.
文摘自从美国FDA（2004年）提出了＂基于模型的药物研发（Model Based Drug Development,MBDD）＂模式,定量药理学在全球范围内成为一个热门学科,MBDD已经列入中国＂十二五＂国家科技重大专项研究。中国药理学会数学药理专业委员会分别于2007年和2010年在南京和厦门成功举办了两届＂定量药理学与新药评价国际学术会议＂（International Sympo-siumof Quantitative Pharmacologyin Drug Development and Regulation,ISQP）,吸引了国内外众多学者参加。为促进我国定量药理学的发展,增进国内外交流,
