Kynamro: how was the first human dose set?

“In addition, on the basis of these non-clinical studies the applicant estimated an acceptable safe starting dose for humans based on the results observed.”

“In a chronic monkey study, multi-focal intimal hyperplasia with mixed inflammatory infiltrates was evident in vascular beds in 2 of 6 monkeys treated for 12 months with 30 mg/kg/week with a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg/week”