Herceptin: how long were the pivotal tox studies?

“The repeated-dose toxicity evaluation of trastuzumab is based on a four-week study in rhesus monkeys and 12- and 26-week studies in cynomolgus monkeys.”

“The repeated-dose toxicity evaluation of trastuzumab is based on a four-week study in rhesus monkeys and 12- and 26-week studies in cynomolgus monkeys.”

“In intravenous embryo-fetal development studies in cynomolgus monkeys after repeated administration, the fetal serum levels were 10-33% of the respective maternal concentrations.”