Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2010 Mar;87(3):270-1. doi: 10.1038/clpt.2009.292.
Selection of a drug dose in pediatrics is generally based on no or incomplete pharmacokinetic data. Traditionally, allometric, or scaling, techniques have been used; however, they have inherent limitations and may not make optimal use of the drug-specific clinical pharmacokinetic information that is available. Modeling is a tool that holds promise. The future challenge is to create a structured approach to determining pediatric doses for new therapeutic agents.
儿科药物剂量的选择通常基于缺乏或不完全的药代动力学数据。传统上,使用了比例或缩放技术;然而,它们具有固有的局限性,并且可能无法最佳利用可用的药物特异性临床药代动力学信息。建模是一种有前途的工具。未来的挑战是为新的治疗药物制定确定儿科剂量的结构化方法。