一个基于风险的,Qtpp驱动的半固体挤出框架 个性化药物的3D打印:整合医院组合和临床试验监管
Maxime Annereau1, Philippe-Henri Secretan2, Bernard Do3
1Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 94805 Villejuif, France.
概括
本研究提出了一个基于风险的框架,用于半固体挤出 (SSE) 3D打印患者特异性药物. 它协调了医院复合和临床试验的监管模式,确保了制药生产的质量和可追溯性.
科学领域:
- 制药科学 制药科学
- 生物医学工程 生物医学工程
- 监管科学 监管科学
背景情况:
- 半固体挤出 (SSE) 3D打印为个性化的口服药物提供了潜力.
- 目前对SSE3D打印的监管途径是分散的,阻碍了广泛采用.
- 医院复合和早期临床试验有不同的,但相关的监管需求.
研究的目的:
- 开发一种基于风险的应用性监管框架,用于SSE3D药品打印.
- 整合医院复合和临床试验监管模型,使用可打印墨水作为制药中间体的概念.
- 支持在分散的制造工厂进行可复制,可追溯和灵活的个性化药品生产.
主要方法:
- 使用质量设计原则开发了一个框架 (ICH Q8-Q11,USP <1220>).
- 定义了关键质量属性 (CQA),关键过程参数 (CPP) 和过程中控制 (IPC).
- 按风险分层化活性药物成分 (API),并将它们与使用儿科用例经验数据的质量控制策略进行映射.
主要成果:
- 建立了一个统一的监管模型,用于集中和照顾点的SSE3D打印.
- 创建了两个表格,以指导基于风险的质量控制策略决策 (IPC与完整的GMP).
- 该框架在各种API和儿科用例中显示出适用性,包括trimethoprim-sulfamethoxazole,cyclophosphamide,tamoxifen和isoleucine.
结论:
- 协调模型解决了SSE3D打印中的监管模两可.
- 它使基于科学的质量控制决策成为可能,确保安全性和有效性.
- 该框架支持儿科和罕见病医学方面的创新,同时确保可复制和可追溯的制药生产.
关键词:
通过3D打印打印3D打印.质量目标产品简介质量目标产品简介关键的质量属性 关键的质量属性分散的制造业去中心化制造业医院复合体的医院复合体在工艺过程中进行控制.儿科药物 儿科药物可打印的墨水 (制药中间体)监管协调与监管协调是指监管协调与监管协调的过程.半固体挤出方式更多相关视频
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