“This was demonstrated in some of the studies that used cyclosporine A as a comparator including the pivotal 26-week study in rats and 39- week study in monkeys.”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗
Pivotal GLP studies
26-week rat and 39-week monkey studies
“This was demonstrated in some of the studies that used cyclosporine A as a comparator including the pivotal 26-week study in rats and 39- week study in monkeys.”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗
Route in tox
Oral gavage
“Repeat-dose toxicity studies have been performed in rat and cynomolgus monkey using oral (gavage) administration.”