Adquey: which tox species, and why?

“Pivotal repeat-dose toxicity studies were conducted in rats (dermal), dogs (subcutaneous), and minipigs (dermal).”

“The dog is the most appropriate animal species for the major metabolites.”

“In nonclinical studies, OPA-15406 and OPC-271 were used as codenames for difamilast.”

“Pivotal repeat-dose toxicity studies were conducted in rats (dermal), dogs (subcutaneous), and minipigs (dermal).”

“a fertility and early embryonic development study in rats, two embryofetal development studies in rats and rabbits, a prenatal and postnatal development study in rats, and two juvenile animal toxicity studies in rats.”

“In 2-year dermal carcinogenicity studies in rats and mice, no test article-related neoplastic findings were observed in rats or mice that received difamilast at dermal doses up to 3% (3.7 to 10 times the MRHD based on AUC comparison).”

“In nonclinical studies, OPA-15406 and OPC-271 were used as codenames for difamilast.”