Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Editor(s): Danuta J. Herzyk, Jeanine L. Bussiere

Published Online: 29 FEB 2008

Print ISBN: 9780470122389

Online ISBN: 9780470386385

DOI: 10.1002/9780470386385

About this Book

  • An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates
  • Helps readers understand the significance of the methods and approaches to immunotoxicology testing
  • Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing
  • Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system
  • Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing

Table of contents

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  1. Part I: Current Regulatory Expectations for Immunotoxicity Evaluation of Pharmaceuticals

  2. Part II: Weight of Evidence Review: A New Strategy in Immunotoxicology

  3. Part III: Nonclinical Core Immunotoxicity Testing in Drug Development

  4. Part IV: Extended Immunotoxicology Assessment: ex vivo Models

    1. Chapter 11

      Application of Flow Cytometry in Drug Development (pages 141–159)

      Padma Narayanan, Renold J. Capocasale, Nianyu Li and Peter J. Bugelski

  5. Part V: Extended Immunotoxicology Assessment: in vivo Models

  6. Part VI: Immunotoxicity Testing in Biopharmaceutical Development

  7. Part VII: Development of Vaccines

  8. Part VIII: Testing for Drug Hypersensitivity

  9. Part IX: Testing for Developmental Immunotoxicity

  10. Part X: New Methods in Assessing Immunomodulation, Immunotoxicity, and Immunogenicity

  11. Part XI: Bridging Immunotoxicology to Clinical Drug Development

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