Considerations on nonclinical studies for immunotoxicity of monoclonal antibodies
10.7501/j.issn.1674-6376.2017.09.010
- VernacularTitle:单克隆抗体非临床免疫毒性研究的考虑要点
- Author:
ping Li YAN
1
;
min Xiao HU
;
li Hong ZHENG
;
Lan YANG
;
Ping CAO
;
Shuang WU
;
xue Hai WANG
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
mAbs;
immunotoxicity;
immunogenicity;
nonclinical study
- From:
Drug Evaluation Research
2017;40(9):1248-1253
- CountryChina
- Language:Chinese
-
Abstract:
Most monoclonal antibodies (mAbs) can induce immune responses.For immunomodulatory mAbs,immunotoxicity is the major toxicity.This article summarizes the characteristics of immunotoxicity,the factors associated with immunotoxicity,and the general considerations of nonclinical studies and evaluations.Before the clinical trials,comprehensive nonclinical studies on immunotoxicityshould be step by step conductedbased on mAbs' characteristics.If needed,some additional studies should be conducted.Attention should be paid to combination of in vivo and in vitro studies,combination of animal species and humanex vivo cells,and multiple approaches for studies.
