中国临床药理学杂志2024，Vol.40Issue(20)：3061-3064,4.DOI:10.13699/j.cnki.1001-6821.2024.20.031
肿瘤治疗性mRNA疫苗非临床评价的考虑
Consideration on the non-clinical evaluation of therapeutic mRNA vaccines for tumors
吴爽 1王寅 1尹华静 1李峥 1尹茂山 1于冰1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
Abstract
Therapeutic mRNA vaccine for tumors attracted much attention as a new type of tumor treatment,and most products are in the preclinical and clinical research stage,and there has not post-market drug.However,the non-clinical evaluation of therapeutic mRNA vaccines for tumors is more complicated,due to their target features,mechanisms,delivery patterns,and the cross-species differences of immune system.The choice of animal model is not only content of the clinical effectiveness,and it was a key factor of toxicity assessment.In this work,the challenges for non-clinical evaluation of therapeutic mRNA vaccines for tumors are discussed,and the compliant requirements are reviewed,and the general considerations are suggested.关键词
肿瘤治疗性mRNA疫苗/非临床研究/动物模型Key words
therapeutic mRNA vaccine for tumors/non-clinical evaluation/animal model分类
医药卫生引用本文复制引用
吴爽,王寅,尹华静,李峥,尹茂山,于冰..肿瘤治疗性mRNA疫苗非临床评价的考虑[J].中国临床药理学杂志,2024,40(20):3061-3064,4.
