Lampit: how long were the pivotal tox studies?

“Pivotal studies included a 13-week study in rats and dog studies of 8, 16, 30, and 52 weeks.”

“None of the repeated-dose toxicology studies were GLP-compliant. Pivotal studies included a 13-week study in rats and dog studies of 8, 16, 30, and 52 weeks.”

“Beagle dogs (n=4/sex/group) were dosed with vehicle, or 30, 60, 120, or 240 mg/kg/day BAY 2502 (nifurtimox) administered orally in gelatin capsules for 52 weeks.”