“The GLP-compliant repeat-dose toxicology studies with up to 13 weeks of dosing were conducted in mice and dogs with animals dosed twice daily via oral gavage.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Why that species
In vitro metabolism in mouse and dog liver microsomes similar to human; no unique human metabolites
“In vitro metabolism in liver microsomes from the toxicological test species, mouse and dog, and humans was similar and there were no unique human metabolites.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In the 13-week toxicology study in dogs, animals were given ziftomenib at doses of 6, 20, or 60 mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗