Preclinical Development Handbook: Toxicology

Preclinical Development Handbook: Toxicology

Editor(s): Shayne Cox Gad

Published Online: 27 AUG 2007

Print ISBN: 9780470248461

Online ISBN: 9780470249055

DOI: 10.1002/9780470249055

About this Book

A clear, straightforward resource to guide you through preclinical drug development

Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques.

Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Among the key topics covered are:

In vitro mammalian cytogenetics tests


Carcinogenicity studies

The pharmacogenomics of personalized medicine

Bridging studies

Toxicogenomics and toxicoproteomics

Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage.

This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Table of contents

    1. You have free access to this content
    2. Chapter 2

      Use of Project Teams in Preclinical Development (pages 65–79)

      Dorothy M. K. Keefe, Joanne M. Bowen and Joanne M. Gibson

    3. Chapter 7

      In Vivo Genotoxicity Assays (pages 169–211)

      Andreas Hartmann, Krista L. Dobo and Hans-Jörg Martus

    4. Chapter 17

      Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling (pages 581–609)

      Duncan Armstrong, Jacques Migeon, Michael G. Rolf, Joanne Bowes, Mark Crawford and Jean-Pierre Valentin

    5. Chapter 18

      Current Practices in Safety Pharmacology (pages 611–694)

      Alan S. Bass, Peter K. S. Siegl, Gary A. Gintant, Dennis J. Murphy and Roger D. Porsolt

    6. Chapter 22

      Genomics (pages 801–838)

      Dimitri Semizarov and Eric A. G. Blomme

    7. Chapter 24

      Toxicogenomics in Preclinical Development (pages 867–910)

      Eric A. G. Blomme, Dimitri Semizarov and Jeffrey F. Waring

    8. You have free access to this content