22. Immunotoxicology in Nonclinical Studies

  1. William J. Brock2,
  2. Barbara Mounho3 and
  3. Lijie Fu4
  1. Florence G. Burleson PhD, and
  2. Stefanie C.M. Burleson PhD

Published Online: 9 MAY 2014

DOI: 10.1002/9781118873922.ch22

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies

How to Cite

Burleson, F. G. and Burleson, S. C.M. (2014) Immunotoxicology in Nonclinical Studies, in The Role of the Study Director in Nonclinical Studies (eds W. J. Brock, B. Mounho and L. Fu), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118873922.ch22

Editor Information

  1. 2

    Brock Scientific Consulting, Montgomery Village, MD

  2. 3

    ToxStrategies, Inc. Bend, OR

  3. 4

    SNBL, Beijing, China

Author Information

  1. Burleson Research Technologies, Inc., Morrisville, NC

Publication History

  1. Published Online: 9 MAY 2014
  2. Published Print: 6 JUN 2014

ISBN Information

Print ISBN: 9781118370391

Online ISBN: 9781118873922



  • immunogenicity;
  • immunotoxicology;
  • international regulations;
  • nonclinical studies


This chapter provides a general overview of the immune system, immunotoxicology, and immune dysregulation, and introduces the international regulations that address immunotoxicity testing. Information is also provided on the types of tests that are available and what a Study Director needs to know when designing studies to evaluate the immunotoxic potential of a drug or chemical. Immune mechanisms are broadly classified as innate immunity or adaptive immunity. Immunogenicity has implications for immunotoxicology if the formation of antibody affects the effectiveness/dose of the drug, or if it allows for development of antibodies to the homologous native entity. Immunotoxicity tests used for immunotoxicologic evaluations can be broadly categorized as screening assays, functional assays, and host resistance studies. The focus of immunotoxicology has traditionally been the suppression of immune responses and the association of immune suppression and clinical disease.