“Inavolisib was evaluated in GLP-compliant, repeat-dose toxicology studies in Sprague-Dawley rats and Beagle dogs following once daily oral administration, consistent with the clinical route of administration and intended dosing schedule, for up to 3 months in duration.”
✓ VerifiedFDA multi-discipline review, p. 40Source ↗
Why that species
Target protein homology, in vivo pharmacodynamics, adequate exposure and human-like metabolic profile
“The rat and dog were selected as the toxicology species based on high protein homology of the target, the demonstration of in vivo pharmacodynamics, adequate in vivo exposure, and comparable in vivo metabolic profile to humans.”