增强分析程序开发在促进通过既定条件通过批准后变化的作用
Douglas Kirkpatrick1, Nirzari Gupta2, Ramesh Gopalaswamy3
1United States Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 645 S Newstead Ave, St. Louis, 63110, Missouri, USA. dkirkpa3@gmail.com.
The AAPS journal
|March 15, 2025
概括
国际协调理事会 (ICH) Q12和Q14指导方针为经过批准后的分析程序管理提供了灵活性. 本案例研究表明,应用这些准则可以获得对变化的监管灵活性,从而优化药品生命周期.
科学领域:
- 制药科学 制药科学
- 监管科学 监管科学
- 分析化学 分析化学
背景情况:
- 国际协调理事会 (ICH) Q12指南增强了制药分析程序的生命周期管理灵活性.
- ICH Q12引入了诸如既定条件 (EC) 等概念,以简化批准后的变化,超越传统的补充流程.
- ICH Q14提供了关于利用分析程序开发数据来支持这些变化的指导.
研究的目的:
- 为了说明ICH Q12和Q14原则对分析程序的实际应用.
- 展示如何确定,提议和证明分析程序ECs对监管提交.
- 为了解决ICH Q12和Q14未实现的潜力,因为在利用开发数据以实现监管灵活性方面存在不确定性.
主要方法:
- 采用案例研究方法,以示范分析程序ECs的确定和理由.
- 该研究概述了定义报告类别和确定不被认为是EC的元素的过程.
- 它描述了这些信息如何在监管提交框架内呈现.
主要成果:
- 案例研究提供了建立分析程序ECs的具体例子.
- 它展示了如何使用开发数据来支持科学合理和基于风险的批准后变化.
- 这些发现说明了实现分析程序修改更大的监管灵活性的途径.
结论:
- 通过有效利用分析开发数据,可以实现ICH Q12和Q14的全部潜力.
- 应用本案例研究中展示的原则可以导致分析程序的更有效的生命周期管理.
- 这种方法支持科学合理的,基于风险的变化,增强药物开发的监管灵活性.
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