Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials

被引：0
|
作者：
Yeung, Cindy Hoi Ting [1 ]
Verstegen, Ruud H. J. [1 ,2 ]
Greenberg, Rachel [3 ,4 ]
Lewis, Tamorah Rae [1 ,2 ]
机构：
[1] Hosp Sick Children, Div Clin Pharmacol & Toxicol, Toronto, ON, Canada
[2] Univ Toronto, Dept Pediat, Toronto, ON, Canada
[3] Duke Clin Res Inst, Durham, NC USA
[4] Duke Univ, Sch Med, Dept Pediat, Durham, NC USA
来源：
FRONTIERS IN PEDIATRICS | 2024年 / 11卷
关键词：
neonate; clinical trial; pharmacokinetic; pharmacogenetic; dose; pharmacodynamic; PATENT DUCTUS-ARTERIOSUS; THERAPEUTIC INDEX; DEVELOPMENTAL-CHANGES; INFANTS; SIMULATION; CHILDREN; DRUGS; AGE;
D O I：
10.3389/fped.2023.1345969
中图分类号：
R72 [儿科学];
学科分类号：
100202 ;
摘要：
Core clinical pharmacology principles must be considered when designing and executing neonatal clinical trials. In this review, the authors discuss important aspects of drug dose selection, pharmacokinetics, pharmacogenetics and pharmacodynamics that stakeholders may consider when undertaking a neonatal or infant clinical trial.
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页数：11
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