Verquvo: which tox species, and why?

“The portfolio of toxicology includes repeat dose toxicology studies up to 6 months duration in rats, up to 39 weeks in dogs, 2-year rodent carcinogenicity studies, a standard battery of genetic toxicology assays, developmental and reproductive toxicology and juvenile animal studies.”

“From the pharmacokinetic point of view, mouse, rat and dog were the most relevant species for non-clinical efficacy and safety studies.”

“Repeated dose toxicity studies were conducted up to 13 weeks in mice, up to 6 months in rats, and 39 weeks in dogs.”

“The portfolio of toxicology includes repeat dose toxicology studies up to 6 months duration in rats, up to 39 weeks in dogs, 2-year rodent carcinogenicity studies, a standard battery of genetic toxicology assays, developmental and reproductive toxicology and juvenile animal studies.”

“in reproductive and developmental toxicity studies (including embryo-fetal development studies in rats and rabbits, fertility and early embryonic development and a pre- and postnatal development study in rats, and juvenile toxicity studies in rats)”

“Carcinogenicity was evaluated in 2-year studies conducted in CD1 mice and Wistar rats.”

“Repeated dose toxicity studies were conducted up to 13 weeks in mice, up to 6 months in rats, and 39 weeks in dogs.”