Problem: Pharmacokinetic and toxicokinetic studies, using both single and repeated intravenous dosage protocols, were performed mainly in monkeys. These studies showed that H-mab was readily cleared by standard catabolic pathways for antibodies. No activity was observed in the Ames bacterial mutagenicity assay or genotoxicity tests. No effects were seen in offspring when the mouse version of the Mab was given to either male or female mice at the time of conception, or to the female during pregnancy. No carcinogenicity studies were performed. Why was the drug given only via i.v., and not oral, administration? Why were monkeys used as the main test species for the few animal studies performed at the pre-clinical testing stage? b. What general statements can you make about the potential toxicity of H-mab? Need Assignment Help?