关闭系统药物传输器件的当前行业实践,用于亲肠道药物产品的药物传输器件
Isabella de Jong1, David Cheng Thiam Tan2, Christian Lehermayr3
1Genentech (A Member of the Roche Group), Pharmaceutical Development, 1 DNA Way, South San Francisco, CA, 94080, USA.
Journal of pharmaceutical sciences
|February 1, 2025
概括
封闭系统药物传输装置 (CSTD) 对于处理危险药物至关重要,但它们的使用范围超出了危险状态. 本研究回顾了CSTD评估和风险管理策略,为更安全的临床使用提供了建议.
科学领域:
- 医疗保健安全 医疗保健安全
- 制药技术 制药技术 制药技术
- 临床试验的管理管理.
背景情况:
- 美国药典 (USP) <800>和国家职业安全与健康研究所 (NIOSH) 提供了使用封闭系统药物传输装置 (CSTD) 处理危险药物的指导方针.
- 在临床环境中,CSTD经常被使用,无论特定药物的危险分类如何.
- 现有的文献提供了关于CSTD评估和风险评估方法的见解.
研究的目的:
- 审查评估封闭系统药物传输装置 (CSTD) 的现有策略.
- 评估医药行业当前在临床研究中对CSTD评估和管理的做法.
- 为减轻与CSTD使用相关的风险提出建议.
主要方法:
- 审查CSTD评估和风险评估的先前出版物.
- 在制药行业内进行的一项调查,以了解临床研究当前的CSTD评估和管理策略.
主要成果:
- 从先前的研究中确定了CSTD的各种评估和风险评估策略.
- 制药行业的调查显示,CSTD评估和临床研究管理的方法各不相同.
- 目前的做法表明需要标准化风险减轻策略.
结论:
- 建议建议加强在医疗保健中安全使用CSTD.
- 需要改进的关键领域包括CSTD测试考虑,全面的风险评估和清晰的通信协议.
- 实施这些建议可以帮助减轻与在临床环境中使用CSTD相关的风险.
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