对比使用的调查分析 人类因素 流程 过程
Megan O Conrad1, Mary Beth Privitera2, Molly E Laird3
1Mechanical Engineering, University of Detroit Mercy, Detroit, MI, USA.
Human factors in healthcare
|January 1, 2026
概括
通用药物-设备组合产品需要人类因素研究才能获得FDA的批准. 专家们发现这个过程是系统的,但面临的挑战是样本大小,错误计算和数据采集.
科学领域:
- 监管科学 监管科学
- 人类因素工程 人类因素工程
- 制药发展 制药发展
背景情况:
- 缩写的新药申请 (ANDA) 途径需要仿制药-设备组合产品来证明药物等价性和设备可互换性.
- 美国食品和药物管理局 (FDA) 2017年指南草案概述了对这些产品进行比较使用人体因素 (CUHF) 研究的要求.
研究的目的:
- 调查人类因素利益相关者关于他们对FDA关于CUHF研究指南草案的经验.
- 确定用于仿制药-药物组合产品的CUHF过程中的使用方法和潜在缺口.
主要方法:
- 对人类因素专家进行了调查问卷 (10个问题),随后进行了虚拟采访 (30分钟).
- 参与者参与了为FDA批准准备通用组合产品的准备工作.
- 采访成绩单通过对话题进行编码来分析.
主要成果:
- 人类因素专家赞赏指导草案中值分析的系统性和具体预期.
- 主要挑战包括与其他FDA指导相比目标的变化,样本大小计算的困难,获得历史设备数据,以及缺少错误计算,分类和严重性评估的方法.
结论:
- 这些发现突出了FDA对CUHF研究的指导草案的改进领域.
- 这些确定的需求将为拟议的比较人类因素方法的开发提供信息.
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