Major factors influencing quality of neuropathology evaluation of drug toxicology
10.7501/j.issn.1674-6376.2017.09.031
- VernacularTitle:影响药物毒性神经病理学评价质量的主要因素
- Author:
Zhe QU
1
;
Zhi LIN
;
jun Jian L(U)
;
tao Gui HUO
;
wei Yan YANG
;
Di ZHANG
;
Shuo ZHANG
;
Yan HUO
;
chao Xing GENG
;
Bo XUE
;
LI WANG
Author Information
1. 中国食品药品检定研究院国家药物安全评价监测中心、药物非临床安全评价研究北京市重点实验室
- Keywords:
toxicology;
neuropathology;
small-molecule drugs;
preclinical safety evaluation;
neurotoxicity;
new drug development
- From:
Drug Evaluation Research
2017;40(9):1348-1354
- CountryChina
- Language:Chinese
-
Abstract:
Neurotoxicity is one common adverse effect caused by many drugs or compounds.In the early phase of new drug development,it is necessary to screen for neurotoxicants.Neurotoxicity studies in nonhuman primates (NHP) are used to evaluate the neurotoxicity of small-molecule drugs or vaccines that may affect the nervous system across the blood-brain barrier during preclinical safety assessment.Toxicologic pathological evaluation or neuropathological examination is the "gold standard" for the evaluation of drug neurotoxicity in preclinical drug safety studies.In this paper,the majory factors influencing the quality of neuropathology evaluation in toxicology,including the general strategy of neuropathology evaluation,the optimal timing of evaluation,the specific blood-brain barrier in the nervous system,the method of sampling in the histopathology of nerve tissue,and the interference of artificial artifacts in diagnosis of neuropathology,were detailly analyzed in order to provide a reference for setting guidelines of neurotoxicity risk assessment in China and pathologists and toxicologists engaged in nonclinical neurotoxicity studies.
