“The pivotal (GLP-compliant) oral toxicity studies were conducted in Sprague Dawley rat and minipig (Gottingen, Hanford).”
✓ VerifiedFDA pharmacology/toxicology review, p. 4Source ↗
Why that species
Minipig used as non-rodent after a dog study was stopped for emesis, tremors and other signs at all doses
“An additional study was initiated in beagle dog but was discontinued due to emesis, retching, tremors, loose feces, and increases in respiratory rate at all doses, including the low dose of 62.5 mg/kg PB/20.83 mg/kg TUDCA.”
✓ VerifiedFDA pharmacology/toxicology review, p. 46Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In vivo toxicology studies were conducted using AMX0035.”
✓ VerifiedFDA pharmacology/toxicology review, p. 46Source ↗