在医院药学准备中实施印刷技术 - - 关于医疗当局的机会和挑战的采访研究
Maria Rautamo1, Hanna M Tolonen1, Viivi Peltoniemi2
1Faculty of Pharmacy, University of Helsinki, Helsinki, Finland; HUS Pharmacy, HUS Helsinki University Hospital, Helsinki, Finland.
三维 (3D) 打印为医院提供了个性化医疗的机会. 欧洲监管机构看到了潜力,但优先考虑安全和质量,强调需要为3D打印药品制定明确的指导方针.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 医学技术 医学技术 医学技术
- 监管科学是一种监管科学.
背景情况:
- 三维 (3D) 打印使医院能够定制制药制造,提供个性化剂量和剂型.
- 目前,欧洲对3D打印制药的监管框架尚未确定.
- 医院药房和制药公司可以在3D打印计划上合作.
研究的目的:
- 调查欧洲药品当局对在医院实施3D打印的看法.
- 评估3D打印制药制造工艺和质量的监管考虑因素.
- 检查医院药房和制药公司之间的合作模式.
主要方法:
- 与欧洲药品管理机构的一个子集进行半结构面试 (n=5/27).
- 采访以预定义的场景为指导,用于在医院中实施3D打印.
- 面试数据的定性内容分析.
主要成果:
- 3D打印被视为制药制造业的转型技术.
- 个性化药物生产是一个关键的机会,但安全性和质量是主要关注点.
- 他们注意到参与者招募的挑战.
结论:
- 对于3D打印药品,需要明确的监管准则.
- 强有力的质量控制措施对于确保3D打印药物的安全性和有效性至关重要.
- 合作模式需要进一步研究.
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