This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug. It details steps in the preclinical process including: prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, toxicity, modeling, and, regulations. It includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage.