人口药理动力学 (PopPK) 支持生物产品的儿科剂量
Brianna Eales1, Nada A Helal2, Olivia Vattelana3
1Department of Pharmacology and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, TX, USA.
Journal of clinical pharmacology
|August 16, 2024
概括
种群药动力学 (PopPK) 分析对于儿科生物药物剂量至关重要. 超过一半的经批准的具有儿科适用的生物药物使用PopPK来确定或验证儿科剂量,有助于剂量选择和推断.
科学领域:
- 药理计量和药物开发研究
- 儿科药理学 儿科药理学
- 生物药物和生物类似药物
背景情况:
- 儿童药物开发需要量身定制的剂量策略,特别是对于新生物产品.
- 像FDA这样的监管机构批准了具有儿科指示的生物制品,需要强有力的剂量建议.
- 种群药动力学 (PopPK) 是了解不同患者种群中的药物行为的一个关键工具.
研究的目的:
- 评估PopPK的利用和影响,以支持FDA批准的生物药物产品的儿科剂量.
- 审查儿科标签,剂量策略以及PopPK在剂量选择和验证中的作用.
- 通过药量测量识别趋势并为未来的儿科药物开发计划提供信息.
主要方法:
- 对美国食品和药物管理局批准的生物药物产品标签 (2002-2021) 的系统审查.
- 对剂量方案,试验类型以及FDA审查文件和产品标签中明确提到PopPK的分析.
- 从Drugs@FDA,PubMed和clinicaltrials.gov收集数据,以获得全面的试验细节.
主要成果:
- 在169种已批准的生物制品中,78种 (46%) 具有儿科适应症和剂量建议.
- 在这些78种产品中,PopPK分析在40种产品 (51%) 的剂量选择,预测或验证中发挥了关键作用.
- 批准的3期儿科试验很常见 (64%),PopPK在各种场景中告知了剂量,包括从成人数据中推断.
结论:
- PopPK分析对于确定和验证生物药物的儿科剂量至关重要.
- 应用PopPK支持明智的剂量决策,特别是当儿科数据有限时.
- 从过去的PopPK应用中学习可以优化未来的儿科生物药物开发.
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