Application of Non-Commercial(Q)SAR Software in the Assessment of Genotoxic Impurities
At present,both domestic and foreign regulations require the control of genotoxic impurities in drugs.When there is a lack of mutagenicity and carcinogenicity data,pharmaceutical companies mostly use commercial softwares to evaluate impurities,which is expensive.FDA has recommended a non-com-mercial evaluation software and accepted its evaluation results.This article introduces the non-commercial evaluation software and evaluates the prediction results of commercial and non-commercial softwares through examples.The results show that the prediction results of the non-commercial software has certain reference value and can be promoted for use to save enterprise costs.
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