摘要
规范的药品管理是药物Ⅰ期临床试验得以顺利进行的根本,需要通过硬件和软件的不断投入来提升药品管理的质量。文章认为药品管理员和研究者在药品管理各环节中应严格执行标准操作规程和相关管理制度,保护受试者的权益,从而提高药物临床试验的质量。
Standardized drug management is the base for successful completion of phase I clinical trials. It is necessary to improve the quality of drug management by constantly raising funds for ＂hardware and software＂. This paper argues that drug administrators and investigators are obliged to strictly execute standard operating procedure and relevant management system and protect subjects＇ rights to improve the quality of drug clinical trials.
出处
《江苏科技信息》
2017年第15期27-29,共3页
Jiangsu Science and Technology Information
基金
国家自然科学基金青年科学基金项目
项目名称:外用酮康唑与醋酸地塞米松相互作用的相关机制研究
项目编号:81602788
关键词
Ⅰ期临床试验
药品管理
标准操作规程
phase I clinical trials
drug management
standard operating procedure
