Immunotoxicology Strategies for Pharmaceutical Safety Assessment

DESCRIPTION

· 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

Introduction to Immunotoxicology (Jack H. Dean).

Chapter 1: Current Regulatory Expectations for Immunotoxicity Evaluation of Pharmaceuticals (Kenneth L. Hastings).

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

2.1. Clinical Pathology as Crucial Insight into Immunotoxicity Testing (Ellen Evans).
2.2. Histomorphology of the Immune System: A Basic Step in Assessing Immunotoxicity (Patrick Haley).
2.3. Need for Specialized Immunotoxicity Tests (Kazuchi Nakamura).
2.4. Specific Drug-Induced Immunotoxicity: Immune-Mediated Hemolytic Anemia (Raj Krishnaraj).

Chapter 3: Nonclinical Core Immunotoxicity Testing in Drug Development.

3.1. Evaluation of Immunosuppression Potential by Immune Function Tests.
3.2. Evaluation of Drug Effects on Immune Cell Phenotypes (Laurie Iciek).

Chapter 4: Extended Immunotoxicology Assessment: Ex Vivo Models.

4.1. Functional Cellular Responses and Cytokine Profiles (Elizabeth R. Gore).
4.2. Application of Flow Cytometry in Drug Development (Padma Narayanan, Nianyu Li, and Peter J. Bugelski).

Chapter 5: Extended Immunotoxicology Assessment: In Vivo Models.

5.1. Animal Models of Host Resistance (Gary R. Burleson and Florence G. Burleson).
5.2. Approaches to Evaluation of Autoimmunity (Danuta J. Herzyk).

Chapter 6: Immunotoxicity Testing in Biopharmaceutical Development.

6.1. Differentiation between Desired Immunomodulation and Potential Immunotoxicity (Jeanine L. Bussiere and Barbara Mounho).
6.2. Relevant Immune Tests across Different Species and Surrogate Models (Jeanine L. Bussiere).
6.3. Anti-Drug Antibody Responses in Preclinical Studies and Their Implications (Barbara Mounho).

Chapter 7: Development of Vaccines.

7.1. Pharmacological Immunogenicity and Adverse Responses to Vaccines (Mary Kate Hart, Mark Bolanowski and Robert V. House).
7.2. Immunotoxicological Concerns for Vaccines and Adjuvants (Catherine Kaplanski, Jose Lebron, Jayanthi Wolf and Brian Ledwith).

Chapter 8: Testing for Drug Hypersensitivity.

8.1. Systemic Hypersensitivity (Raymond Pieters).
8.2. Nonclinical Models to Assess Respiratory Hypersensitivity Potential (Curtis C. Maier).

Chapter 9: Testing for Developmental Immunotoxicity.

9.1. Developmental Immunotoxicity in Rodents (Rodney R. Dietert and Leigh Ann Burns-Naas).
9.2. Developmental immunotoxicity in Non-Human Primates (Pauline L. Martin and Eberhard Buse).

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

10.1. Alternative Animal Models for Immunomodulation and Immunotoxicity (Peter J. Bugelski).
10.2 Animal Models for Preclinical Comparative Immunogenicity Testing (Daniel Wierda).
10.3. T-Cell Epitopes and Minimization of Immunogenicity (Harald Kropshoffer and Thomas Singer).

Chapter 11: Bridging Immunotoxicology to Clinical Drug Development (Ian Gourley and Jacques Descotes).