摘要
药品研发过程中,药学研究阶段是其最为基础的一个部分,在药学研究期间,积极构建药物研发质量管理体系来加强对其研究结果科学性、规范性和真实性的管控,保证药品研发的质量和效率,从而为药品最终的安全性和有效性提供保障。该文分析了药学研究部门药物研发质量管理体系的构建及药学研究结果的真实规范性,并且对药物研发质量管理体系的构建总结相应的经验及建议,以期为药学研究过程的质量管理带来一定参考指导。
In the process of drug research and development,the pharmaceutical research stage is the most basic part.During the pharmaceutical research period,the drug research and development quality management system is actively constructed to strengthen the control of the scientific,standardized and authenticity of its research results,to ensure that the drug quality and efficiency of research and development to provide a guarantee for the final safety and effectiveness of the drug.The article analyzes the construction of the pharmaceutical research department's drug R&D quality management system and the authenticity of the pharmaceutical research results,and summarizes the corresponding experience and suggestions on the construction of the drug R&D quality management system,hoping to bring reference to the quality management of the pharmaceutical research process.
作者
查娟
ZHA Juan(Zhejiang Innovation Biological Co.,Ltd.Shaoxing,Zhejiang Province,312366 China)
出处
《中国卫生产业》
2021年第7期58-60,共3页
China Health Industry
关键词
药物研发
质量管理体系
体系构建
药学研究
结果
真实性
Drug research and development
Quality management system
System construction
Pharmaceutical research
Results
Authenticity
