Non-clinical assessment of the carcinogenic potential of human insulin analogues

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Current effective version

Adopted guideline

Reference numberCPMP/SWP/372/01
Published15/11/2001
KeywordsInsulin analogues, carcinogenic potential, mitogenic potential, in vitro assays, in vivo assays
DescriptionThis document provides guidance on the general approach to the assessment of potential mitogenicity and carcinogenicity of new insulin analogues.


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