Klisyri: which tox species, and why?

“Tirbanibulin was evaluated in repeat-dose general toxicity studies involving topical administration to the skin of rats and minipigs for up to 4 weeks, as well as in studies that involved oral dosing of rats and dogs for up to 4 weeks.”

“This study involves exposure to the to-be-marketed formulation once daily for five days via the clinical route of exposure, utilizing the best available nonclinical model for topical application to skin.”

“In a general toxicity study conducted with rats, the animals were orally dosed with tirbanibulin at dosages of 0, 2.5, 5, and 10 mg/kg/day in males and 0, 1.25, 2.5, and 4 mg/kg/day in females (administered in two equal daily doses).”