Nourianz: how long were the pivotal tox studies?

“Dog: Re-analysis of brain sections from the 26- and 52-week studies in dog (26-week: 0, 0 (vehicle), 16, 80, or 400 mg/kg/day; 52-week: 0, 10, 30, or 100 mg/kg/day) did not reveal evidence of brain mineralization”

“in the 26-week toxicity study in Sprague-Dawley rat (0, 3, 6, 30, or 160 mg/kg/day) at the highest dose tested, based on a re-examination of brain sections from these studies.) Brain mineralization was not detected in beagle dog in the 26- or 52-week toxicity studies”

“Pneumonitis with septal thickening was appreciated after oral dosing (both gavage and capsular administrations) in rats and dogs.”