Rituxan: how was the first human dose set?

“A repeated pilot pharmacology/toxicology experiment in Cynomolgus monkeys (using 16.8 mg/kg doses) demonstrated the relationship between exposure of multiple injections of rituximab to the degree of B–cell depletion in the peripheral blood and bone marrow, as well as within the lymphatic tissues. This experiment formed the basis for the initial dose escalating study in humans.”

“No effect other than the expected pharmacological depletion of B–cells in peripheral blood as well as in lymphatic tissues was observed in toxicity studies.”