Duvyzat: which tox species, and why?

“The toxicity of givinostat was investigated after single and repeated i.v. and oral administration for up to 13 weeks in mice, 26 weeks in rats 4 weeks in dogs and 39 weeks in monkeys.”

“Mice and rats were chosen as pharmacologically responsive rodent species, whereas monkeys were selected due to the limited gastrointestinal tolerability of givinostat in the 4 weeks repeat-dose toxicity study in dogs.”

“The toxicity of orally administered givinostat was investigated in single and repeat-dose studies for up to 13 weeks in mice, 26 weeks in rats 4 weeks in dogs and 39 weeks in monkeys.”