【摘 要】
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Pediatric drug research is currently one of the new frontiers for clinical pharmacology.With the necessity of pediatric drug research and the special ethical considerations in pediatric clinical trial
【机 构】
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Medical Research Center, Subei People's Hospital (Clinical Medical School of Yangzhou University),
【出 处】
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第四届定量药理学与新药评价国际会议·2013(The 4th International Symposium in Qu
论文部分内容阅读
Pediatric drug research is currently one of the new frontiers for clinical pharmacology.With the necessity of pediatric drug research and the special ethical considerations in pediatric clinical trials, pediatric physiologically based pharmacokinetic (PBPK) model have the great potential to scaling systemic exposure and pharmacokinetics from adult to children and to support the "First-in-children" dosefinding and pediatric clinical trial design.In this review, we compare the capabilities of PBPK models with compartmental models, and interpret the special issues in pediatric PBPK models and its modeling strategies.We also utilize literature cases for academy, industry, and FDA to exemplify the role of pediatric PBPK models in pediatric drug research and its limitations and prospects
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