Fotivda: which tox species, and why?

“The selection of animal models to be used in toxicology and safety pharmacology studies (rats and monkeys) was based on PK and/or metabolic profiles of tivozanib.”

“Comparison of the metabolic profile of tivozanib in liver microsomes showed that monkey most closely resembled the human, followed by the rat. These data provided support for species selection.”

“Oral administration of tivozanib in rats for 26 weeks produced non-adverse decreases in body weights, abnormal whitening of the teeth and changes in hematology/clinical chemistry at 0.08 mg/kg/day.”