药械组合产品可比性分析研究中的要点  

Key Points in the Comparative Analysis for Drug-device Combination Products

作　　者：卢望丁 葛渊源 陈桂良 王健[1] 何军[1] 罗华菲[1] 张景辰 LU Wangding;GE Yuanyuan;CHEN Guiliang;WANG Jian;HE Jun;LUO Huafei;ZHANG Jingchen(National Pharmaceutical Engineering Research Center,Shanghai 201203;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210)

机构地区：[1]药物制剂国家工程研究中心,上海201203 [2]上海药品审评核查中心,上海201210

出　　处：《中国医药工业杂志》2022年第12期1683-1688,共6页Chinese Journal of Pharmaceuticals

摘　　要：药械组合产品是一类特殊的药品,具有相对较高的技术壁垒,因而其仿制产品的研究一直是热点和难点问题,成功率较低。与普通制剂相比,药械组合仿制产品在研究时需要充分考虑人为因素工程研究。国内目前尚没有针对人为因素工程研究相关的指导原则。该研究基于美国FDA最新推出的《仿制药中提交的药械组合产品的比较分析和相关人为因素研究行业指南草案》《药物-器械和生物制品-器械组合产品桥接的指导原则》进行因素对比分析,并结合实例阐述了研究内容以及关键考虑点供研究者参考。Drug-device combination products are a special class of drug product with relatively high technical barriers.The research of their generic products has been a hot and difficult issue.However,the success rate of the product development is extremely low.Compared with ordinary dosage forms,human factor should be systematically considered in the development of generic drug-device products.Currently,there is no guideline for human factors engineering research in China.This study conducts a comparative analysis of factors based on the latest guidelines from FDA,such as"Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA:Draft Guidance for Industry",and"Bridging for Drug-Device and Biologic-Device Combination Products:Draft Guidance for Industry".Several case studies are applied for the illustration of some key considerations on development of generic drug-device combination products to provide a reference for researchers.

关 键 词：药械组合产品 仿制产品 人因工程 

分 类 号：R944.9[医药卫生—药剂学]