模型主文件的作用,用于与FDA共享,接受和通信
Lanyan Fang1, Yuqing Gong1, Andrew C Hooker2
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, Maryland, 20993, USA.
The AAPS journal
|February 27, 2024
概括
模型总文件 (MMF) 对于在仿制药开发中共享验证的定量模型至关重要. 改善货币市场基金的接受和与FDA的沟通对于监管成功至关重要.
科学领域:
- 药理计量学和计算毒理学
- 药物开发和监管科学 药物开发和监管科学
- 量化药理学 量化药理学
背景情况:
- 在仿制药开发中越来越多地使用模型综合证据 (MIE),因此需要标准化模式共享和监管接受的方法.
- 模型主文件 (MMF) 是作为一个可共享,可验证的定量模型的框架,适用于监管提交.
- 工业和监管机构,包括美国食品和药物管理局 (FDA),认识到货币货币基金的潜在好处.
研究的目的:
- 总结了2022年FDA和CRCG关于在仿制药开发中利用建模的最佳实践研讨会的讨论.
- 启动关于在药物开发和监管过程中应用货币市场基金的进一步实用性和最佳实践的对话.
- 突出货币市场基金的公认优势和利益相关方合作的需要.
主要方法:
- 美国食品和药物管理局和复杂仿制药研究中心 (CRCG) 在2022年召开了一场虚拟公共研讨会.
- 演讲和小组讨论的重点是模型共享,接受和与FDA的沟通.
- 本报告综合了从研讨会中获得的关键教训和成果.
主要成果:
- 包括模型开发商,行业和FDA在内的利益相关者承认了货币货币基金的潜在优势.
- 研讨会是建立货币市场基金利用最佳实践的基础讨论.
- 显然需要持续对话和合作,以促进对货币货币基金的统一理解.
结论:
- 货币货币基金为MIE中定量模型的监管接受提供了一个有希望的框架.
- 利益相关者之间的进一步合作是必不可少的,以建立货币货币基金应用的标准化最佳实践.
- 计划于2024年5月2日至3日举行后续研讨会,以解决监管提交中货币市场基金的实际方面.
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