化学新药研发企业对临床试验用药品委托制备的研发质量管理实践  

R&D quality management practice for commissioned preparation of investigational medicinal products in chemical new drug R&D enterprise

作　　者：陈辉[1] 刘俊耀 夏广新[1] CHEN Hui;LIU Junyao;XIA Guangxin(Central Research Institute,Shanghai Pharmaceuticals Holding Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]上海医药集团股份有限公司中央研究院,上海201203

出　　处：《上海医药》2024年第1期65-68,79,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：临床试验用药品是化学新药研究与试验发展(以下简称研发)过程中里程碑式的产品,其制备的质量直接影响到临床受试者的用药安全性和临床试验结果的有效性。为确保临床试验用药品在委托制备过程中安全、有效且质量可控,本文阐明了化学新药药学研究在不同阶段下的研究重点,深入分析了工作中对临床试验用药品委托制备的质量管理所遇到的问题,探索出以“技术转出资料管理”“委托合同”“质量协议”三位一体,协同对临床试验用药品委托制备研发质量管理的模式,以期为新药研发企业的研发质量管理提供借鉴与思考。Investigational medicinal products are milestone products in the research and experimental development(R&D)of new chemical drug,and the quality of their preparation can directly affect the safety of clinical subjects and the validity of clinical trial results.In order to ensure the safety,effectiveness and controllable quality of investigational medicinal products in the process of commissioned preparation,this article clarifies the research emphases of pharmaceutical research on new chemical drugs in different stages and analyses the problems encountered in the quality management of commissioned preparation of investigational medicinal products,explores a trinity mode of“technology transfer data management”,“commissioning contract”and“quality agreement”to cooperate with the R&D quality management of commissioned preparation of investigational medicinal products and to provide reference for the R&D quality management of chemical new drug R&D enterprises.

关 键 词：化学新药 临床试验用药品 委托合同 质量协议 技术转出资料管理 

分 类 号：R951[医药卫生—药学]