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).”

“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.”

“Tirbanibulin was evaluated in a battery of reproductive toxicology studies involving oral dosing of rats and rabbits, as summarized below.”

“Not applicable, as the proposed use does not involve chronic exposure.”

“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.”