摘要
针对开展临床保护效力研究的创新性疫苗,本文归纳总结了临床研发中应重点关注的问题,如新疫苗效力的有效性和安全性评价、免疫原性研究、批间一致性研究等,并从现行法规和相关指导原则的角度对新疫苗临床技术审评要求进行了系统阐述;进一步重申了关键性临床试验对临床数据资料以及试验管理和质量保证的考虑要点。
This article systematically summarizes the development of innovative vaccines in China, specifically focusing on the key issues associated with the development of clinical protective efficacy studies, such as evaluation for efficacy and safety of vaccines clinical trial, immunogenicity studies, clinical consistency between batches, etc. It also details the review requirements of the innovative vaccine based on registrative regulations, guidelines, and relevant guidance documents, with an emphasis on the importance of the requirements data management of pivotal clinical trials and quality assurance to innovative vaccines.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第12期1367-1370,1417,共5页
Chinese Journal of New Drugs
关键词
创新性
疫苗
临床试验
评价
innovative
vaccine
clinical trials
evaluation
