Examination and assessment of target organ toxicity in toxicologic pathology of preclinical safety evaluation of drugs
10.7501/j.issn.1674-6376.2017.09.008
- VernacularTitle:临床前药物安全评价毒性病理学靶器官毒性的检查及评价
- Author:
tao Gui HUO
1
;
iun Jian LV
;
Zhi LIN
;
Zhe QU
;
wei Yan YANG
;
Di ZHANG
;
chao Xing GENG
;
Yan HUO
;
Xue WANG
;
Bo LI
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:
preclinical safety evaluation of drugs;
toxicologic pathology;
target organ toxicity;
clinical pathology
- From:
Drug Evaluation Research
2017;40(9):1235-1240
- CountryChina
- Language:Chinese
-
Abstract:
Examination and assessment of target organ toxicity in toxicologic pathology of preclinical safety evaluation of drugs should combine the results of the gross pathology,histopathology and clinical pathology examination data in a well-considered,stepwise approach.In addition,the nomenclature and diagnostic criteria recommended by INHAND should be used to avoid subjective and inappropriate diagnosis.In this paper,we briefly introduced the basic principles for the examination of organ toxicity in toxicology studies,gross pathology,histopathology,diagnostic approach,procedures,and considerations,international harmonization of diagnostic term and criteria,clinical pathology parameters analysis,results of a well-concerted combination of anatomical and clinical pathology data so as to provide some reference for the examination and assessment of target organ toxicity in toxicologic pathology in the field ofpreclinical safety evaluation of drugs in China.
