“Daily oral administration of alpelisib was assessed in repeat-dose toxicity studies for up to 3 months in rats and dogs, consistent with the clinical route of administration and intended dosing schedule.”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗
Why that species
Pharmacodynamic target and major human metabolic pathways represented in rat and dog
“The pharmacodynamic target and the major pathways of alpelisib metabolism in humans were all represented in these species.”
“Daily oral administration of alpelisib was assessed in repeat-dose toxicity studies for up to 3 months in rats and dogs, consistent with the clinical route of administration and intended dosing schedule.”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗