Barhemsys: which tox species, and why?

“amisulpride was administered IV to Charles River Wistar (Crl:WI(Han)) rats at doses of 0, 2, 5 and 10 mg/kg/day.”

“Based on extensive clinical experience with amisulpride, outside of the Unites States, at higher doses, the Division agreed that a 28-day repeat dose toxicity in a single species would be adequate for the proposed indication in which only a single dose will be administered.”

“amisulpride was administered IV to Charles River Wistar (Crl:WI(Han)) rats at doses of 0, 2, 5 and 10 mg/kg/day.”