摘要
目的通过对几起试验用药品管理中存在问题的实例分析,提出改进建议。方法分析近2年试验用药品管理中的几起典型问题实例,依照《中华人民共和国药品管理法》《药物临床试验质量管理规范》等法规进行分析。结果与结论试验用药品包装、冷链运输、人员更换等方面存在不规范,会直接影响药品试验质量和药品安全。
Objective To provide the suggestions of improvement and the reference for colleagues through the analysis of several cases of the problems existing in the clinical investigational product administration. Methods The several typical cases of the problems in the clinical investigational product administration for nearly two years were analyzed according to the law and regulations of the Drug Ad- ministration Law of the People＇s Republic of China and the Criterions for the Quality Control of Clinical Trial of Drugs. Results and Conclusion The unstandardization exists in the aspects of the investigational product packaging, cold- chain transportation and person- nel change and directly affects the quality of drug testing and the drug safety.
出处
《中国药业》
CAS
2014年第4期66-67,共2页
China Pharmaceuticals
关键词
试验用药品
药品管理
监察员
investigational product
drug administration
supervisor
