Preclinical Drug Development  book cover
2nd Edition

Preclinical Drug Development

ISBN 9781420084726
Published September 25, 2009 by CRC Press
380 Pages 16 Color & 58 B/W Illustrations

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Book Description

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.

Table of Contents

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


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' excellent book covering important aspects of preclinical drug development. All chapters are well-written...' - The British Toxicology Society Newsletter