The Scope of Preclinical Drug Development: An Introduction and Framework. Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical Data to Human Populations. Transgenic Animals for Preclinical Drug Development. Pharmacokinetics/ADME of Small Molecules. Pharmacokinetics/ADME of Large Molecules. Preclinical Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Formulation and Route of Administration - Influencing Drug. Assessment of Pharmacokinetics and Drug Activity: Isolated Organ. Alternate Methods for Assessing Absorption, Metabolism and Routes of Toxicity Evaluations: ICH Guidelines and Current Practice. Application of Pathology in Safety Assessment. Principles of Toxicogenomics: Implications for Preclinical Drug Development. Utilizing the Preclinical Database to Support Clinical Drug Development.