“This includes a single-dose rat study, a battery of definitive repeat-dose general toxicity studies in rats (up to 26 weeks) and dogs (up to 39 weeks), a full battery of genetic toxicity studies, mouse and rat carcinogenicity studies”
26-week rat and 39-week dog oral studies (with 4-week recovery), plus 13-week rat and dog studies
“13-week repeat dose studies (with 4 weeks recovery) in the rat and the dog, 26-week repeat dose study (with 4 weeks recovery) in the rat, and 39-week repeat dose study (with 4 weeks recovery) in the dog.”