Concerns of the genotoxicity evaluation of drugs
GAO Mei
ZHANG Rong
XU Na
CHEN Kai
WANG Xin-xin
ZHANG Dai-zhou
Abstract：Genotoxicity evaluation is an important part of the non-clinical safety evaluation of drugs,which is closely related to carcinogenicity and reproductive toxicity.The purpose of genotoxicity test is to detect the mutagenicity and potential carcinogenic effects of the test articles,and a comprehensive assessment of their genotoxicity potential is an important link for drugs to enter clinical trials and marketing.The standard test battery for genotoxicity includes in vivo and in vitro tests with a variety of endpoints.In this paper,the concerns of genotoxicity evaluation were expounded from the personnel qualification,laboratory management,dose formulation,test system,key stages of experimental implementation,etc.,so as to provide reference for the conducting of genotoxicity study.The safety assessment should be conducted in strict compliance with the good laboratory practice for nonclinical laboratory studies(GLP)by the testing facility,and the quality of genotoxicity tests should be improved constantly.
Keywords：druggenotoxicityin vivoin vitrogood laboratory practice for nonclinical laboratory studies
Publication Date：2024-07-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1417-1423 )