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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development
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Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

机译：儿科药发发疗效外推的曝光匹配

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摘要

During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching adult systemic exposures as the basis for dose selection in pediatric trials submitted to the US Food and Drug Administration (FDA) between 1998 and 2012. The trial design of pediatric pharmacokinetic (PK) studies and the pediatric and adult systemic exposure data were obtained from FDA publicly available databases containing reviews of pediatric trials. Exposure-matching approaches that were used as the basis for pediatric dose selection were reviewed. The PK data from the adult and pediatric populations were used to quantify exposure agreement between the 2 patient populations. The main measures were the pediatric PK studies' trial design elements and drug systemic exposures (adult and pediatric). There were 31 products (86 trials) with full or partial extrapolation of efficacy with an available PK assessment. Pediatric exposures had a range of mean C-max and AUC ratios (pediatric/adult) of 0.63 to 4.19 and 0.36 to 3.60, respectively. Seven of the 86 trials (8.1%) had a predefined acceptance boundary used to match adult exposures. The key PK parameter was consistently predefined for antiviral and anti-infective products. Approaches to match exposure in children and adults varied across products. A consistent approach for systemic exposure matching and evaluating pediatric PK studies is needed to guide future pediatric trials.
机译：在药物开发期间，匹配成年人的药物曝光是当疗效部分或完全推断的儿科患者中的剂量选择的常见方法。这是对将成人全身曝光的方法进行系统审查，作为提交给美国食品和药物管理局（FDA）的儿科试验中的剂量选择的基础。儿科药代动力学（PK）研究的试验设计和小儿和成人全身曝光数据是从包含儿科试验审查的FDA公开可用数据库获得。综述了用作儿科剂量选择基础的曝光匹配方法。来自成人和儿科群体的PK数据用于量化2个患者人群之间的暴露协议。主要措施是儿科PK研究的试验设计元素和药物系统性暴露（成人和儿科）。有31种产品（86项试验），具有可用的PK评估的全部或部分外推。儿科暴露的范围为0.63至4.19和0.36至3.60的平均C-MAX和AUC比率（儿科/成人）。 86项试验中的七个（8.1％）具有用于匹配成人曝光的预定义接受边界。关键PK参数始终预定抗病毒和抗感染产品。匹配儿童和成人暴露的方法各种各样的产品。需要一种始终如一的全身暴露匹配和评估儿科PK研究的方法，以引导未来的儿科试验。

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