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: PharmacokineticsModeling and simula
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.