Abstract:In the process of drug clinical trials, the experimental drug management is an important part in the process of study. According to the main problems in the management of experimental drugs in Drug Clinical Trial Institution, Zhongshan People's Hospital, such as management oversight in experimental drugs, the registration form is complicated; the drug management of professional department is so disorder that it can not be managed normatively; the hand-written prescription increases the workload of researchers; there is no monitoring system of temperature and humidity, so it is difficult to guarantee the drug efficacy and safety, and so on, through using the measures of revising and perfecting experimental drug management system and standard operation procedure, establishing institutional pharmacy, taking free drug coding, using the temperature and humidity monitoring system to strengthen the experimental drug monitoring. It is emphasized that the institutions should formulate the experimental drug management system and standard operation procedure for their own institutions and continue to improve base on the actual situation, in order to improve the operability of experimental drug management, so as to ensure the safety and efficacy of experimental drugs.
刘峰 邓贵新 李雪芹 王桂凤. 试验药物管理中存在的问题及对策探讨[J]. 中国医药导报, 2017, 14(20): 128-131.
LIU Feng DENG Guixin LI Xueqin WANG Guifeng. Discussion on the problems and countermeasures in the management of experimental drugs. 中国医药导报, 2017, 14(20): 128-131.