疫苗的临床前安全性评价  

Preclinical safety assessment of vaccines

作　　者：张若明[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2008年第13期1176-1179,共4页Chinese Journal of New Drugs

摘　　要：疫苗主要用于大规模健康人群,尤其是儿童,其安全性至关重要。临床前安全性评价是疫苗研发的重要环节之一。国家食品药品监督管理局药品审评中心于2005年公布了《预防用生物制品临床前安全性评价技术审评一般原则》,该指导原则是国内首篇用以指导疫苗临床前安全性评价技术审评工作的指导原则。文中在该指导原则的基础上,结合作者在疫苗临床前安全性评价技术审评中的认识,从疫苗临床前安全性评价的必要性、主要安全性担忧、国内外相关注册指导原则和主要技术要求方面加以综述。Vaccines are applied to large numbers of healthy people, predominantly to healthy children. Therefore, their safety should be emphasized. Preclinical safety assessment is an important step in new vaccine development. Center for drug evaluation of State Food and Drug Administration has proposed Guidelines on preclinical evaluation of vaccines for reviewers in 2005, which is the first guideline for the reviewers in the center for drug evaluation in reviewing preclinical safety of vaccines. Based on the guideline and the review experience of the author, the necessity of performing preclinical safety assessment, major toxicological concerns, related regulatory guidelines, and outline of the toxicology studies were reviewed in this article.

关 键 词：疫苗 临床前安全性 药品注册 

分 类 号：R915.1[医药卫生—微生物与生化药学] R994.2[医药卫生—药学]