“The pivotal repeat dose toxicity studies consisted of a 26-week repeat-dose toxicity study and a 52-week immunotoxicity study, both performed in cynomolgus monkeys.”
Cynomolgus monkey 26-week SC (10, 100 mg/kg/week) and 52-week SC immunotoxicity study (50, 100 mg/kg/week)
“The animals were administered 10 and 100 mg/kg/week s.c. certolizumab pegol and 50 and 100 mg/kg/week s.c. in the 26- and 52- week study, respectively.”
Subcutaneous (weekly); intravenous in 4-week monkey and rat studies
“The animals were administered 10 and 100 mg/kg/week s.c. certolizumab pegol and 50 and 100 mg/kg/week s.c. in the 26- and 52- week study, respectively.”