Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

Editor(s): Joy A. Cavagnaro

Published Online: 14 NOV 2007

Print ISBN: 9780470108840

Online ISBN: 9780470292549

DOI: 10.1002/9780470292549

About this Book

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."
-From the Afterword by Anthony D. Dayan

Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials:

  • Includes an overview of biopharmaceuticals with information on regulation and methods of production
  • Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan
  • Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals
  • Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals
  • Covers transitioning from preclinical development to clinical trials

Table of contents

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    1. You have free access to this content
  1. Part I: Background

  2. Part II: Principles of Preclinical Development

  3. Part III: Current Practices in Preclinical Development

  4. Part IV: Selection of Relevant Species

    1. Chapter 9

      Selection of Relevant Species (pages 179–205)

      Meena Subramanyam, Nicola Rinaldi, Elisabeth Mertsching and David Hutto

  5. Part V: Safety/Toxicity Endpoints

    1. Chapter 18

      Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates (pages 379–397)

      Gerhard F. Weinbauer, Werner Frings, Antje Fuchs, Michael Niehaus and Ingrid Osterburg

  6. Part VI: Specific Considerations Based on Product Class

    1. Chapter 27

      Immunomodulatory Biopharmaceuticals and Risk of Neoplasia (pages 601–632)

      Peter J. Bugelski, Clifford Sachs, Joel Cornacoff, Pauline Martin and George Treacy

    2. Chapter 29

      Preclinical Safety Evaluation of Immunotoxins (pages 649–667)

      Jennifer G. Brown, Joycelyn Entwistle, Nick Glover and Glen C. MacDonald

  7. Part VII: Preclinical Study Design, Implementation, and Analysis

  8. Part VIII: Transitioning from Preclinical Development to Clinical Trials

  9. Part IX: Afterword

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

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