Nonclinical evaluation and concerns of preventive vaccines
10.13200/j.cnki.cjb.004342
- VernacularTitle:预防用疫苗的非临床评价及审评考虑
- Author:
WANG Yin
- Publication Type:Journal Article
- Keywords:
Vaccine;
Adjuvant;
Nonclinical evaluation;
Regulatory guideline
- From:
Chinese Journal of Biologicals
2024;37(11):1389-1394
- CountryChina
- Language:Chinese
-
Abstract:
Nonclinical evaluation of vaccines is an important part of innovative vaccine research and development. Information on vaccine efficacy and safety is obtained through nonclinical research to support the clinical development and licensure of the vaccine. In this paper, combined with existing vaccine evaluation experience, the strategies, considerations and concerns of vaccine nonclinical evaluation are summarized by consulting the relevant domestic and foreign literature and guidelines of vaccine nonclinical evaluation in recent years, so as to provide a reference for vaccine researchers. Because of the different characteristics and concerns of therapeutic vaccines, the discussion in this paper mainly focuses on innovative preventive vaccines.
