摘要
疫苗临床试验主要用于健康个体,大部分用于儿童,具有受试者人数多,试验场地大,疫苗冷链管理要求高等特殊性。国家食品药品监督管理局按照2007年10月开始实施的《药品注册管理办法》,于2009年开始对新申请承担疫苗临床试验的疾病控制中心实施临床试验现场核查。文中对在疫苗临床研究过程中应注意的有关问题进行探讨,为试验机构疫苗临床试验的规范化操作提供参考。
The clinical trial on vaccine is applicable mainly for healthy individual （mostly for children）. It has special characteristics, such as many subjects, large trial place, and strict management requirement of vaccine cold chain. According to Provisions for Drug Registration released on October 2007, SFDA implemented on-site inspection to the disease control center who is recently applying for conducting the clinical trials on vaccine from this year. This article explores the problems during the clinical trial on vaccine and the standard operation of its trial institutions, so as to provide for future reference.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2009年第20期1935-1936,1953,共3页
Chinese Journal of New Drugs
关键词
疫苗
临床试验
现场核查
vaccine
clinical trial
on-site inspection
