Qinlock: which tox species, and why?

“To assess its safety, the Applicant conducted GLP‐compliant toxicology studies of daily oral administration of ripretinib up to 13 weeks in Sprague Dawley rats and Beagle dogs.”

“The justification for the relevance of these test species includes: in vitro studies of metabolic stability and metabolite identification comparing mouse, rat, dog, monkey, and human, where rat and/or dog were demonstrated to form the same metabolites as humans.”

“To assess its safety, the Applicant conducted GLP‐compliant toxicology studies of daily oral administration of ripretinib up to 13 weeks in Sprague Dawley rats and Beagle dogs.”

“To assess its safety, the Applicant conducted GLP‐compliant toxicology studies of daily oral administration of ripretinib up to 13 weeks in Sprague Dawley rats and Beagle dogs.”

“The conducted studies included dose-range finding embryo-foetal development studies in rats and rabbits and a pivotal embryo-foetal development study in rats.”

“Carcinogenicity studies have not been conducted with ripretinib.”

“To assess its safety, the Applicant conducted GLP‐compliant toxicology studies of daily oral administration of ripretinib up to 13 weeks in Sprague Dawley rats and Beagle dogs.”