良好的临床实践的更新:ICH E8关键组成部分的框架
Madeleine Whitehead1, Melissa Suprin2, Tashan Mistree3
1Roche, Hexagon Place, Shire Park, Falcon Way, Welwyn Garden City, AL7 1TW, UK. madeleine.whitehead@roche.com.
Therapeutic innovation & regulatory science
|December 1, 2023
概括
国际协调理事会更新了良好的临床实践 (GCP) 指南,转向积极主动的,基于风险的方法. 本文阐明了关键的ICH E8主题,如设计质量 (QbD) 和质量关键 (CtQ),以改善临床开发.
科学领域:
- 临床研究方法论临床研究方法论
- 制药发展 制药发展
- 监管科学是一种监管科学.
背景情况:
- 国际协调委员会 (ICH) 更新了良好的临床实践 (GCP) 指南.
- 修订促进了主动的,基于风险的方法,而不是一个适合所有人的模式.
- ICH E8为临床开发中的质量提供了一个框架.
研究的目的:
- 为了提高对特定ICH E8主题的理解.
- 为了澄清设计质量 (QbD),质量至关重要 (CtQ),适合目的和利益相关方参与.
- 支持在临床开发中建立一个坚实的质量基础.
主要方法:
- 分析来自TransCelerate成员公司的直接反.
- 专注于被确定为ICH E8.8中变化最多和开放于解释的主题.
- 发展TransCelerate框架以扩展关键主题.
主要成果:
- 确定设计质量 (QbD),质量关键 (CtQ),适合目的和利益相关方参与是需要澄清的关键领域.
- 强调了临床研究向主动,基于风险的方法的转变.
- 提供了一个框架来支持这些概念的实际应用.
结论:
- 对ICH E8原则的更好理解对于有效的临床开发至关重要.
- 跨加速框架为实施QbD,CtQ,适合目的和利益相关方参与提供了实际指导.
- 采用这些原则加强了制药研究质量的基础.
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