江西省医疗机构医院制剂现状调研及产业发展研究  

Research on the Situation and Industry Development of Hospital Preparation in Medical Institutions in Jiangxi Province

作　　者：朱慧婷[1] 刘琬婧 易鹏飞[1] 张彦忠 ZHU Huiting;LIU Wanjing;YI Pengfei;ZHANG Yanzhong(Jiangxi Provincial Children's Hospital,Nanchang Jiangxi 330006,China;Jiangxi Provincial Drug Administration Pharmaceutical Production Division,Nanchang Jiangxi 330029,China;Beijing Sun-Novo Pharmaceutical Research Co.Ltd.,Beijing 102200,China)

机构地区：[1]江西省儿童医院,江西南昌330006 [2]江西省药品监督管理局,江西南昌330029 [3]北京阳光诺和药物研究股份有限公司,北京102200

出　　处：《药品评价》2023年第2期131-134,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2021KY05);江西省中医药管理局科技计划项目(2021B628)。

摘　　要：探讨和分析新形势下江西省医疗机构医院制剂的质量研究、应用管理和发展现状。药品监管部门、医疗机构及药品研发单位多方协作,通过文献调研、问卷调查及访谈,对江西省医院医疗机构制剂的临床应用、生产与质量控制及产业化布局进行调研摸底,分析医院制剂的质量研究、应用管理与发展模式方面存在的问题。医疗机构医院制剂是满足临床需求的重要补充,但近年来其发展遇到了巨大挑战,而真实世界研究证据将为医疗机构提供了一个很好的解决办法,实现医疗机构制剂的长期健康可持续发展。To discuss the use,quality control,existing problems and future trends of preparations in medical institutions of the hospitals in Jiangxi province under the new situation.Drug regulatory units,clinical hospital units,and drug RD units cooperated with each other to investigate the clinical application,production and quality control,and industrial layout of preparations in medical institutions of Jiangxi hospitals through literature research,questionnaires and interviews.The preparation of medical institutions is an important link to meet the clinical needs,but its development has met great challenges in recent years.The real world research evidence provide a good solution for medical institutions to achieve the long-term healthy and sustainable development of medical institutions' preparations.

关 键 词：药用制剂 医疗机构制剂 现状 趋势 产业化 真实世界研究 

分 类 号：R95[医药卫生—药学]