R&D quality management practice for commissioned preparation of investigational medicinal products in chemical new drug R&D enterprise
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.
chemical new druginvestigational medicinal productscommission contractquality agreementtechnology transfer data management
万方数据
维普
