“Based on available data, both species were determined to be pharmacologically relevant for toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“Thirteen-week repeat-dose oral toxicity and toxicokinetic studies were conducted in the rat (0, 0.25, 1, or 4 mg/kg selinexor; 5 total doses given every 2-week period) and monkey (0, 0.1, 0.3, 1 mg/kg selinexor; 2 to 3 times/week) to support the NDA.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗