“tolerability and the 6-month (Q weekly dosing x 26 weeks) repeat-dose toxicity studies in cynomolgus monkeys.”
✓ VerifiedFDA pharmacology/toxicology review, p. 6Source ↗
Pivotal GLP studies
26-week GLP IV monkey study, once weekly, with 8-week recovery
“Study title: Twenty-six week intravenous toxicity and toxicokinetic study with pertuzumab in cynomolgus monkeys with an 8-week recovery period”
✓ VerifiedFDA pharmacology/toxicology review, p. 30Source ↗
Route in tox
Intravenous
“The purpose of this study was to evaluate multiple dose PK of pertuzumab in cynomolgus monkeys following IV administration once per week for 26 weeks.”
✓ VerifiedFDA pharmacology/toxicology review, p. 30Source ↗