摘要
疫苗临床研究是疫苗研发过程中必须经历的投入最大、风险最高、最为关键的决定性阶段。近年来,我国疫苗临床研究事业迅猛发展,国家也在不断规范和完善对疫苗临床研究质量的监督和管理。作为疫苗临床研究负责机构,如何切实做好质量控制至关重要。结合近20年疫苗临床研究实践,笔者从质量管理人员、规章制度、标准操作规程、质量控制计划等几个方面对疫苗临床试验过程中的关键环节和质量控制措施进行探讨分析并提出建议。
As the most decisive stage,clinical trial which carries the largest investment as well as the biggest risk is vital in vaccine research and development process. In recent years,China＇s vaccine clinical research has been developing rapidly. The national authority has also gradually standardized and improved supervision and management of quality of vaccine clinical research. As a responsible agency for vaccine clinical trials,how to conduct quality control is very important. Combined with nearly 20 years of vaccine clinical research practice,the authors put forward some suggestions and measures about quality control in key links of vaccine clinical trials from several aspects including quality management personnel,rules and regulations,standard operation procedure and plan of quality control.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第20期2411-2413,2417,共4页
Chinese Journal of New Drugs
基金
国家"十二五"传染病防治科技重大专项(2012ZX1004-703)
关键词
疫苗
临床试验
质量控制
vaccine
clinical trial
quality control
