“The nonclinical program supporting clinical development of Oliceridine included a pharmacology, ADME, general toxicology studies (28 days duration in rats and 14 days duration in monkeys), genetic toxicology, and reproductive toxicity studies.”
✓ VerifiedFDA multi-discipline review, p. 313Source ↗
Pivotal GLP studies
28-day rat and 14-day monkey general toxicity studies
“The nonclinical program supporting clinical development of Oliceridine included a pharmacology, ADME, general toxicology studies (28 days duration in rats and 14 days duration in monkeys), genetic toxicology, and reproductive toxicity studies.”
✓ VerifiedFDA multi-discipline review, p. 313Source ↗
Route in tox
Continuous intravenous infusion
“Intravenous bolus administration is the intended clinical route of administration; however, continuous infusion was selected to maximize daily exposure in the toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 163Source ↗