This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology through the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.
Table of Contents
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