The assessment of carcinogenicity is a pivotal element in the preclinical safety evaluation of pharmaceuticals.The alternative approach to non-clinical carcinogenicity assessment,as outlined in the ICH S1B guidelines,is widely endorsed both domestically and internationally.However,the development of genetically modified mouse models for carcinogenicity poses significant technical challenges within this alternative approach.Since the issued of the ICH S1B guidelines in 1997,China's pharmaceutical industry has heavily relied on costly and lengthy imports from overseas,which are subject to stringent conditions.Moreover,due to monopolied resources being controlled by Western countries,the pharmaceutical industry faces mounting pressure from high costs and unstable supply chains.This article outlines relevant guidelines for carcinogenicity evaluation at home and abroad,introduces the global development,validation,and application history of major carcinogenicity mouse models such as Tg.rasH2,KI.C57-ras V2.0,p53+/-mice;it also looks ahead to establishing independent intellectual property rights for domestically produced carcinogenicity mouse models while standardizing their production and supply.
维普
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