使用肺部区域沉积模型作为局部作用口服吸入药物产品的模型整合证据
Ross L Walenga1, Steven G Chopski2, Jae H Lee2
1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov.
肺部区域沉积建模 (RDM) 提供了一个解决方案,用于评估口服吸入药物产品 (OIDPs) 中的药物输送. 这种方法有助于了解特定区域的肺部输送,促进通用产品的开发和改善患者的获取.
科学领域:
- 药理动力学和药物输送方法
- 呼吸系统医学 呼吸系统医学
- 计算建模 计算建模
背景情况:
- 评估局部作用口服吸入性药物产品 (OIDPs) 的药物输送是具有挑战性的,因为缺乏直接的肺部区域药物度量化.
- 目前的in vivo区域沉积研究存在局限性,包括小样本大小,长时间和2D结果表示.
研究的目的:
- 突出肺部区域沉积建模 (RDM) 的实用性,以评估OIDP的特定区域药物输送.
- 探索RDM如何为OIDPs的体外-体内相关性发展提供信息.
主要方法:
- 使用肺部区域沉积建模 (RDM) 来模拟和理解影响肺部药物输送的物理过程.
- 整合RDM与体外和/或体内数据用于模型验证和参数输入.
- 通过验证过程建立模型的可信性.
主要成果:
- 对于局部行动的OIDP来说,RDM为肺部内的区域特定药物输送提供了有价值的见解.
- 将RDM与实验数据相结合,可以发展出强大的 in vitro-in vivo相关性.
- 可信的RDM可以被认为是模型集成证据 (MIE).
结论:
- 肺部区域沉积建模 (RDM) 是评估口服吸入药物 (OIDP) 中药物输送的强大工具.
- 从RDM获得的模型集成证据 (MIE) 可以促进通用OIDP的开发和批准.
- 这种方法最终可以改善患者获得必要的吸入药物的可用性.
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