Kerendia: which tox species, and why?

“Even so, general toxicity studies using oral gavage exposure are available for mouse, rat and dog, where rat and dog are considered main general toxicology species and have been used for studies of up to 26- and 39-weeks duration respectively.”

“Both species are considered pharmacologically relevant based on appropriate binding data and formation of metabolites.”

“The oral route (oral gavage) has been used throughout the study programme, as this route is the intended clinical route.”

“Even so, general toxicity studies using oral gavage exposure are available for mouse, rat and dog, where rat and dog are considered main general toxicology species and have been used for studies of up to 26- and 39-weeks duration respectively.”

“a full battery of reproductive toxicology studies (including a fertility and early embryonic development study in rat, embryofetal developmental toxicity studies in rat and rabbit and a pre-and postnatal development study in rat)”

“and two 2-year carcinogenicity studies in mouse and rat.”

“Both species are considered pharmacologically relevant based on appropriate binding data and formation of metabolites.”