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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.

Preclinical Drug Development

The Scope of Preclinical Drug Development: An Introduction and Framework; Mark C. Rogge





Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments; P. L. Bullock





Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical





Data to Human Populations; M. N. Martinez





Pharmacokinetics/ADME of Small Molecules; A. D. Ajavon and David R. Taft





Pharmacokinetics/ADME of Large Molecules; R. Braeckman





Preclinical Pharmacokinetic-Pharmacodynamic Modeling and Simulation in Drug Development; P. L. Bonate and P. Vicini





Formulation and Production Strategies for Enhancing Bioavailability of Poorly Absorbed Drugs; A. B. Watts and R. O. Williams III





Transporters Involved in Drug Disposition, Toxicity, and Efficacy; C. Q. Xia and G. T. Miwa





Toxicity Evaluations, ICH Guidelines, and Current Practice; J. L. Larson





Application of Pathology in Safety Assessment; Robert A. Ettlin and David E. Prentice





Utilizing the Preclinical Database to Support Clinical Drug Development; H. Lee





Index