Immunotoxicology Strategies for Pharmaceutical Safety Assessment

DANUTA J. HERZYK, PHD, is the Senior Scientific Director in the Safety Assessment Department of Merck Research Laboratories. She previously worked in immunologic toxicology for GlaxoSmithKline. A member of the Society of Toxicology, Drug Information Association, and American Association of Immunologists, Dr. Herzyk has published over forty articles. She serves on the editorial board of Perspectives in Experimental and Clinical Immunotoxicology.
 
JEANINE L. BUSSIERE, PHD, is an Executive Director of Toxicology at Amgen. She is the author or coauthor of eight book chapters and approximately fifty articles. She is on the editorial board of Journal of Immunotoxicology. Dr. Bussiere is a member of the Society of Toxicology, American College of Toxicology, and Drug Information Association.

A hands-on reference on current immunotoxicology approaches for testing pharmaceuticals
 
An important resource for toxicologists in pharmaceutical and biotechnology areas, this book discusses recently introduced systems for immunotoxicology testing and their applications. Immunotoxicology pharmaceutical safety assessments are important for streamlining the development process and reducing drug candidate attrition. After an introduction to immunotoxicology, Immunotoxicology Strategies for Pharmaceutical Safety Assessment:
 
* Provides an overview of current regulatory expectations for immunotoxicity evaluation of pharmaceuticals
* Relates the preclinical immunotoxicity safety assessments to clinical development
* Offers examples of nonclinical models to study the toxic impacts that pharmaceuticals can have on the immune system
* Includes chapters on safety of vaccines, testing for drug hypersensitivity, and testing for developmental immunotoxicity
* Covers diverse methodologies applied in immunotoxicology studies: flow cytometry to characterize responses of immune cells to drug treatment; immunoassays to address immunogenicity of biopharmaceuticals; molecular immunology to evaluate immune dysregulation at the subcellular level; and in vivo models of immune disorders to characterize potential impairment of host defense to infections, tumors, and autoimmune diseases
 
With chapters contributed by experts from across the pharmaceutical industry, this resource presents immunotoxicity testing from a practical, real-world perspective. This is the current reference for practicing toxicologists in the pharmaceutical industry, industrial and regulatory scientists in drug development, professionals in contract research organizations (CROs) in the pharmaceutical and biotechnology fields, and investigative and regulatory toxicologists.

This core reference explains current strategies for immunotoxicology pharmaceutical safety assessments, which can reduce drug candidate attrition and streamline the development process.

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).

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