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

This document provides guidance on the general approach to the assessment of potential mitogenicity and carcinogenicity of new insulin analogues.

Keywords: Insulin analogues, carcinogenic potential, mitogenic potential, in vitro assays, in vivo assays

Current version

Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues

Adopted Reference Number: CPMP/SWP/372/01