“To assess the safety of selpercatinib, Loxo conducted GLP-compliant toxicology studies of up to 13-weeks in Sprague Dawley rats and Gottingen mini pigs.”
✓ VerifiedFDA multi-discipline review, p. 64Source ↗
Why that species
Relevant rodent and non-rodent species based on pharmacokinetic and metabolic considerations
“Rats (Sprague-Dawley) and minipig (Göttingen) were chosen as relevant rodent and non-rodent species for toxicology program based on pharmacokinetic and metabolic considerations.”
✓ VerifiedFDA multi-discipline review, p. 79Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In a 13-week study in minipigs, male and female animals received selpercatinib at doses of 2, 5, or 15 mg/kg/day for 13 weeks via oral gavage.”
✓ VerifiedFDA multi-discipline review, p. 64Source ↗