“repeat dose toxicity studies (in mice, rats, and monkeys, for up to 39 weeks)”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗
Pivotal GLP studies
GLP 6-month rat and 9-month cynomolgus monkey oral/nasogastric gavage studies
“GLP-compliant repeat-dose toxicity studies of 14 days, 3 months, and 6 months duration were conducted in rats and studies of 2 weeks, 3 months, and 9 months duration were conducted in cynomolgus monkeys. In all studies, doses were administered daily by oral or nasogastric gavage corresponding to the proposed clinical oral dosing regimen.”