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切换不同自动注射器设计的可行性:形成性研究的积极见解 比较性使用 人类因素研究
Chloé Stoll1, Anne Combedazou1, Laurie Brunet-Manquat1
1BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, France.
Expert opinion on drug delivery
|June 10, 2025
概括
切换到通用自动注射器是可行的,可用性是由用户熟悉度驱动的,而不是设备设计. 比较的可用性研究表明,在不同激活机制之间过渡时,风险最小.
科学领域:
- 药物设备组合产品 药物设备组合产品
- 人类因素工程 人类因素工程
- 仿制药是一般的药物制品.
背景情况:
- 患者可以转换为通用药物设备产品,包括自喷器.
- 自动注射器激活机制 (按在皮肤上的按与按) 在原始版本和通用版本之间可能有所不同.
- 确保通用自动注射器的安全性和有效性至关重要.
研究的目的:
- 为通用自动注射器设计提供初步可用性数据.
- 评估不同自动注射器激活机制之间切换的安全性和有效性.
主要方法:
- 进行了两项形成性的比较使用人类因素研究.
- 一个三步候选通用按激活自喷器与原始参考列表设备 (RLD) 自喷器进行了比较.
- 研究1:与4步按激活的RLD相比;研究2:与2步按激活的RLD相比.
主要成果:
- 研究1:80%的参与者相似性;20%的错误率用于通用药物,而RLD的错误率为13.3%.
- 研究2:90%的参与者相似性;通用药的错误率为9%,RLD为0%.
- 参与者的高表现相似性表明切换的可行性.
结论:
- 初步证据支持在没有新的风险的情况下,在不同的自动注射器激活机制之间切换.
- 用户熟悉似乎是影响自动注射器可用性的主要因素.
- 尽管界面有差异,但通用自动注射器的使用可以安全有效.
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