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使用模型主文件来支持口服药物产品开发和监管提交

Yi-Hsien Cheng¹, Arindom Pal¹, Rebecca Moody²

¹Office 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.

Pharmaceutical research

|May 28, 2025

概括

模型总文件 (MMF) 提供了一条简化药物开发和口服剂型监管审查的途径. 全球协调和货币货币基金的技术跟踪可以加速新药的可用性.

科学领域:

制药科学制药科学
监管科学监管科学
计算化学的计算化学

背景情况:

美国食品和药物管理局 (FDA) 和复杂仿制药研究中心 (CRCG) 举办了一场关于模型主文件 (MMF) 的研讨会.
货币货币基金被提议作为支持药物产品开发和加快监管审查的工具.
第二届会议的重点是货币市场基金对口服剂型的应用.

研究的目的:

总结了货币货币基金研讨会第二届会议的讨论和发现.
探索口服药物产品的货币市场基金的框架,实际考虑和监管应用.
突出全球协调和货币货币基金利用技术进步的好处.

主要方法:

总结了一个公开研讨会的记录.
对口服剂型的货币市场基金的介绍和案例研究进行审查.
分析关于货币货币基金开发,验证,提交和生命周期管理的讨论.

主要成果:

货币货币基金为口服药品提供潜在的框架和使用背景 (COU).
讨论了货币市场基金开发,验证和监管提交的实际考虑.
货币货币基金的全球协调可以提高效率并缩短药物开发时间表.
技术可以跟踪货币货币基金的生命周期,确保透明度并促进重复使用.

结论:

货币市场基金,特别是口服剂型,对药物开发和监管过程具有重大优势.
货币市场基金的全球协调对于资源和时间效率至关重要.
货币货币基金生命周期管理的技术解决方案可以提高透明度和下游再利用,加速药物的可用性.

关键词:

药物产品开发药物产品开发模型的主文件 (MMF)建模和模拟 (M&S) 的使用口服用药的剂量形式.监管提交监管提交

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