Qulipta: which tox species, and why?

“The toxicologic and toxicokinetic profile of orally administered atogepant was assessed in a series of single and repeat dose studies in rats and monkeys up to 6- and 9-months’ duration, respectively.”

“The ADME data submitted for rat and rhesus monkey provide supporting evidence for the use of these species in the atogepant toxicity studies.”

“The toxicologic and toxicokinetic profile of orally administered atogepant was assessed in a series of single and repeat dose studies in rats and monkeys up to 6- and 9-months’ duration, respectively.”

“A complete nonclinical package was submitted to the NDA, which included general toxicology studies of up to 6 and 9 months’ duration in rat and monkey, respectively;”

“2-year carcinogenicity studies in mouse and rat; and reproductive and development studies (fertility and early embryonic, embryofetal development, and pre- and postnatal development studies in rat; embryofetal development study in rabbit).”

“2-year carcinogenicity studies in mouse and rat; and reproductive and development studies (fertility and early embryonic, embryofetal development, and pre- and postnatal development studies in rat; embryofetal development study in rabbit).”

“The toxicologic and toxicokinetic profile of orally administered atogepant was assessed in a series of single and repeat dose studies in rats and monkeys up to 6- and 9-months’ duration, respectively.”