The development of drugs within the Developmental Therapeutics Program (DTP) has evolved into two stages that require a toxicological evaluation at each stage. The first involves a preliminary assessment of toxicity in two preclinical animal models with the determination of maximum tolerated doses (MTD) and NOAEL in both species and pharmacokinetics in one of the preclinical animal models. If the drug meets the program criteria for full-scale development, a more complete toxicity evaluation is performed that will lead to the filing of an IND.