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寻找一种共同的人类因素语言,用于注射器件的开发和测试

Megan O Conrad¹, Molly E Laird², Mary Beth Privitera³

¹Mechanical Engineering, University of Detroit Mercy, Detroit, MI, USA.

|August 7, 2025

概括

本文为注射设备用户界面 (UI) 定义建立了一个共同的语言. 这对于人类因素 (HF) 评估和仿制药批准至关重要,确保安全有效的药物供应.

科学领域:

医疗器械医疗器械
人类因素工程人类因素工程
制药科学制药科学

背景情况:

注射装置是用于皮下药物输送的关键药物设备组合产品.
直观的用户界面 (UI) 设计对于患者和护理人员在临床环境之外的安全和有效使用至关重要.
像FDA这样的监管机构要求对新药和仿制药的应用进行人为因素 (HF) 评估.

研究的目的:

编译和定义与注射装置特征相关的关键术语,用于高频评估.
为参与设备开发的工程师,设计师和监管机构建立一个共同的标准化语言.
为了促进HF评估过程,特别是在缩写新药应用 (ANDAs) 中,将仿制与参考设备进行比较.

主要方法:

系统编制注射器械分类和特征的定义.
将定义的设备特征与特定的UI元素和用户任务联系起来.
结构化定义以支持开发,测试和监管审查.

主要成果:

提供了注射器械分类,特征和UI特征的全面词汇表.
这些定义为理解成功使用设备所需的常见任务提供了一个框架.
已建立的共同语言有助于在不同发展阶段对HF进行一致的评估.

结论:

标准化定义对于在注射器件开发中进行强大的人为因素 (HF) 评估至关重要.
这项工作提供了基础词汇,以改善监管提交的沟通和一致性.
定义的术语对于缩写新药申请 (ANDA) 途径尤其具有影响力,简化了通用产品的批准.

关键词:

在 DDCP DDCP 中.笔注射器笔注射器自动注射器自动注射器人类因素人类因素预填注射器注射器预填注射器任务分析任务分析用户界面用户界面

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