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中国仿制药质量关键影响因素分析 |
Study of Key Factors Influencing the Quality of Generic Drug in China |
投稿时间:2020-04-22 修订日期:2020-09-11 |
DOI: |
中文关键词: 仿制药 质量 影响因素 因子分析 |
英文关键词: generic drug quality influencing factors exploratory factor analysis |
基金项目: |
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中文摘要: |
目的:研究中国仿制药质量的关键影响因素。方法:采用问卷调查和探索性因子分析法研究影响仿制药质量的不同主体因素和生产企业内部因素。结果:进行了两轮问卷调查,分别发放了110和170份和问卷,有效回收99和159份。研究结果显示:影响仿制药质量的因素按重要性依次为企业>监管>产业环境>药品使用>政策保障;企业内部影响因素的重要性依次为关键技术>实施操作>风险控制>仪器设备>原辅料质量。结论:仿制药质量受到企业内部因素和监管因素、产业环境因素、使用因素等多种外部因素的影响;生产企业内部因素是影响药品质量的决定因素,其中又以企业的关键生产技术最为重要。 |
英文摘要: |
Objective: To determine the key influencing factors which are significant important for the quality of generic drugs in China. Methods: Questionnaire surveys were conducted and the data collected were assessed using exploratory factor analysis (EFA). Results: Totally 110 and 170 questionnaires were issued separately and 99 and 159 were returned, respectively. Results showed that manufacturers, regulation, industry environment, medicine use and policy support are listed in a descending order regard with the impact severity on the quality of generic drugs, while the order with internal factors is key technologies, operation, risk management, equipment and quality control of incoming materials. Conclusion: Generic drugs’ quality was influenced by factors related with manufacturers, industrial environment, and clinical use, etc. Of all the factors assessed, manufacturer was the most crucial influencing factor on medicine quality. |
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