Preclinical Drug Development

This volume discusses the broad and complicated realm of preclinical drug development. Topics discussed include pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling. The authors also examine lead molecule selection and optimization via profiling and screening using in silico and in vitro toxicity evaluations. The book includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism.

Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials.

Highlights of the Second Edition include:

• Pharmacokinetics
• Modeling and simulation
• Formulation and routes of administration
• Toxicity evaluations
• The assessment of drug absorption and metabolism
• Interspecies scaling
• Lead molecule selection and optimization via profiling
• Screening using in silico and in vitro toxicity evaluations

The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

The Scope of Preclinical Drug Development: An Introduction and Framework. Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments. Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical Data to Human Populations. Pharmacokinetics/ADME of Small Molecules. Pharmacokinetics/ADME of Large Molecules. Preclinical Pharmacokinetic-Pharmacodynamic Modeling and Simulation in Drug Development. Formulation and Production Strategies for Enhancing Bioavailability of Poorly Absorbed Drugs. Transporters Involved in Drug Disposition, Toxicity, and Efficacy. Toxicity Evaluations, ICH Guidelines, and Current Practice. Application of Pathology in Safety Assessment. Utilizing the Preclinical Database to Support Clinical Drug Development. Index.