狭窄治疗指数药物:FDA的经验,观点和操作
Mark Donnelly1, Lanyan Fang1, Rajanikanth Madabushi2
1Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Clinical pharmacology and therapeutics
|November 12, 2024
概括
美国食品和药物管理局 (FDA) 正在改进狭窄治疗指数 (NTI) 药物的标准,以确保仿制药的安全. 这些努力旨在建立公众对NTI药物的信任.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物监管 药物监管 药物监管
- 制药科学 制药科学
背景情况:
- 美国食品和药物管理局 (FDA) 定义狭窄治疗指数 (NTI) 药物是由于小剂量或度变化导致严重不良事件或治疗失败的潜力.
- 美国食品和药物管理局正在积极努力,通过各种举措,建立明确的NTI评估标准,并通过各种举措促进对NTI仿制药品的信心.
- 该NTI药物工作组于2015年成立,旨在创建一种标准化的方法来识别NTI药物,并以透明的方式解决相关的科学和监管挑战.
研究的目的:
- 概述FDA正在进行的努力和建立的工作组,致力于定义和评估狭窄治疗指数 (NTI) 药物.
- 详细介绍NTI药物工作组用于评估潜在的NTI药物产品的特征和标准,以theophylline作为案例.
- 突出NTI药物名称的现状,并强调协调定义对于监管一致性的重要性.
主要方法:
- 审查FDA定义和与狭窄治疗指数 (NTI) 药物相关的倡议.
- 分析NTI药物工作组的形成和目标.
- 检查用于NTI药物评估的五个一般特征,以神素为例.
- 收集有关目前被指定为NTI药物产品及其活性成分的数据.
主要成果:
- 截至2024年1月5日,包括14种不同的活性成分的33种药物产品正式被指定为NTI药物.
- 产品特定指南 (PSG) 用于关于这些NTI药物的仿制药开发.
- 新型传染病药物工作组采用五个特征的框架来评估潜在的新型传染病药物.
结论:
- 美国食品和药物管理局的结构化方法,包括NTI药物工作组,旨在提高通用狭窄治疗指数 (NTI) 药物的安全性和可靠性.
- 跨机构的NTI定义的持续合作和协调对于提高药物开发和监管审查的清晰度和一致性至关重要.
- 正在进行的努力表明了通过确保仿制NTI药物的治疗等价性来保护患者健康的承诺.
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