相关实验视频
Updated: Jun 16, 2025

The Quantification of Injectability by Mechanical Testing
Published on: May 13, 2020
长效注射剂的杆模型主文件
Yuqing Gong1, Robert Hopefl1, Tonglei Li2
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.
美国食品和药物管理局 (FDA) 和CRCG对监管机构提交的模型主文件 (MMF) 进行了探索. 货币货币基金有望改善药物开发的模式共享和效率,特别是长效注射剂.
科学领域:
- 监管科学 监管科学
- 制药科学 制药科学
- 计算建模 计算建模
背景情况:
- 美国食品和药物管理局和CRCG召开了一场关于模型主文件 (MMF) 的研讨会.
- 货币市场基金旨在在监管提交文件中标准化和共享模型整合证据 (MIE).
- 专注于长效注射剂 (LAI) 和复杂的仿制药的应用.
研究的目的:
- 总结关于货币市场基金的潜在监管应用的讨论.
- 探索货币货币基金在LAI产品开发和监管提交中的实用性.
- 确定货币货币基金实施的挑战和考虑因素.
主要方法:
- 来自公开研讨会 (2024年5月2日至3日) 的总结演讲.
- 包括来自小组和小组讨论的见解.
- 审查的案例研究和潜在的货币市场基金在LAI开发中的应用.
主要成果:
- 货币市场基金可以提高模式共享,标准化和监管效率.
- 演讲涵盖了PBPK,多物理和popPK模型中的MMF应用.
- 讨论了模型集成生物等价性 (MI-BE) 框架的潜在实用性.
结论:
- 货币货币基金为模型开发者,行业和监管机构提供了重要的预期好处.
- 对地方政府机构实施货币市场基金既有机遇又有挑战.
- 货币市场基金准备简化复杂药品的监管流程.
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