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ICH M7 Classification Workflow

pdf fileClarke G; Harding A; Johnston LA; Nye WE; Shannon-Little AL; Williams RV; Yeo D;

This resource summarises the ICH M7 classification workflow method which has been developed by Lhasa Limited to aid in the submission of impurities under the ICH M7 guideline. This workflow uses both Derek and Sarah Nexus, along with experimental Ames and carcinogenicity data to predict an ICH M7 class.

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