“Overall, the toxicity profile determined in rat and dog in the non-GLP studies (4-week studies and 26 or 39-week studies with an intermediate 13-week analysis) appears affected a larger number of target organs than the one observed in GLP pivotal studies (two 13-week studies).”
Metabolite profile: dog metabolites mostly represent human; rat has the same metabolites in a different ratio
“The species comparison suggests that metabolites in dog represent mostly the metabolites in human but that the rat also has same metabolites present, although in a different ratio.”
“In a 13-week repeat-dose toxicology study in dogs, animals were orally administered fruquintinib at 0, 0.03, 0.06, or 0.12 mg/kg daily with a 4-week recovery period.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗