Overview

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.

Full Product Details

Author:   Mark Rogge ,  David R. Taft
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Edition:   2nd edition
Volume:   187
Dimensions:   Width: 17.80cm , Height: 2.50cm , Length: 25.40cm
Weight:   0.860kg
ISBN:  

9781420084726

ISBN 10:   1420084720
Pages:   380
Publication Date:   25 September 2009
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

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.

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Mark Rogge, David R. Taft

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