Pharmacologically relevant species with sufficient exposure by the clinical oral route
“The toxicological assessment was performed in pharmacologically relevant species (mouse, rat, rabbit and dog) that were sufficiently exposed to remibrutinib following the intended clinical route of administration (i.e. oral).”
“In a 39-week GLP oral repeat-dose toxicity study in beagle dogs, animals (4/sex/group) were administered doses of 0 (vehicle), 10, 50, and 300 mg/kg/day remibrutinib.”