University of Southern California School of Pharmacy, Los Angeles, California, USA.
Office of Clinical Pharmacology, US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S133-S140. doi: 10.1002/jcph.1864.
Pediatric safety evaluations are an essential part of a pediatric drug development program. Communication of the results of these safety evaluations is primarily accomplished by labeling of the drug either during the initial pediatric drug development program, or during the postmarketing period after drug approval for pediatric patients. During drug development, the dose-adverse drug event (ADE) relationship is an important part of the evaluation, but a consideration for pediatric ADEs that are unrelated to drug dosage must be maintained. Examples of dose-related and non-dose-related ADEs are presented. The failure to label a product for pediatric use has been safety related for a number of development programs. The US Food and Drug Administration's Pediatric Advisory Committee is a primary source of the pediatric postmarketing safety review and has been associated with a number of labeling changes through its ongoing review process. Pediatric drug safety remains a critical part of the assessment of dose-effect relationship in the pediatric patient population during the drug development and postmarketing surveillance process.
儿科安全评估是儿科药物开发计划的重要组成部分。这些安全评估结果的交流主要是通过在初始儿科药物开发计划期间或在药物批准后用于儿科患者的上市后期间对药物进行标签来完成的。在药物开发过程中，剂量-不良药物事件（ADE）关系是评估的重要组成部分，但必须考虑与药物剂量无关的儿科 ADE。本文介绍了剂量相关和非剂量相关 ADE 的例子。未能为儿科用途贴上标签与许多开发计划的安全性有关。美国食品和药物管理局儿科咨询委员会是儿科上市后安全性审查的主要来源，并且通过其正在进行的审查过程与许多标签更改相关联。在药物开发和上市后监测过程中，儿科药物安全性仍然是评估儿科患者人群中剂量-效应关系的关键部分。
