sparse sampling;
population pharmacokinetics;
Bayesian approach;
variable and fixed sampling;
D O I:
暂无
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
(Background and objective:) under bar The objectives of this study were to assess pharmacokinetic parameters (clearance, volume and half-life) in children using sparse sampling population as well as Bayesian (post hoc) approach. (Methods:) under bar Three drugs were selected for this study. Two sparse sampling methods (variable or fixed) using population and Bayesian approaches were used to assess pharmacokinetic parameters in children following a single oral dose. The initial estimates of the model parameters and inter- and intrasubject variability were obtained from the pharmacokinetic studies conducted in adults. The estimated pharmacokinetic parameters using sparse sampling (3 blood samples) were compared with the pharmacokinetic parameters obtained by extensive sampling (greater than or equal to7 blood samples). (Results and conclusions:) under bar The results indicated that both variable and fixed sampling approaches could be used to estimate mean population as well as individual pharmacokinetic parameters in children with fair degree of accuracy. The methods described here can be used to assess either population or individual pharmacokinetic parameters in children, provided there is a prior knowledge of the pharmacokinetics of a drug in adult population.
机构:
US FDA, Div Pharmaceut Evaluat 1, Off Clin Pharmacol & Biopharmaceut, Woodmont Off Ctr 2, Rockville, MD 20852 USAUS FDA, Div Pharmaceut Evaluat 1, Off Clin Pharmacol & Biopharmaceut, Woodmont Off Ctr 2, Rockville, MD 20852 USA
机构:
Anhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Huang, Xiao-hui
Wang, Kun
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Wang, Kun
Huang, Ji-han
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Huang, Ji-han
Xu, Ling
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Xu, Ling
Li, Lu-jin
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Li, Lu-jin
Sheng, Yu-cheng
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
Sheng, Yu-cheng
Zheng, Qing-shan
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h-index: 0
机构:
Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai 20123, Peoples R ChinaAnhui Med Univ, Coll Pharm, Ctr Pharmacokinet, Hefei 230032, Anhui, Peoples R China
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Florence Loingeville
Julie Bertrand
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Julie Bertrand
Thu Thuy Nguyen
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Thu Thuy Nguyen
Satish Sharan
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Satish Sharan
Kairui Feng
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Kairui Feng
Wanjie Sun
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Wanjie Sun
Jing Han
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Jing Han
Stella Grosser
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Stella Grosser
Liang Zhao
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Liang Zhao
Lanyan Fang
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Lanyan Fang
Kathrin Möllenhoff
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Kathrin Möllenhoff
Holger Dette
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research
Holger Dette
France Mentré
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h-index: 0
机构:University of Paris,Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research