Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Ed. by Danuta J. Herzyk and Jeanine L. Bussiere

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 432
• Erscheinungstermin: 1. September 2008
• Englisch
• Abmessung: 236mm x 157mm x 25mm
• Gewicht: 748g
• ISBN-13: 9780470122389
• ISBN-10: 0470122382
• Artikelnr.: 23593647

Autorenporträt

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.

Inhaltsangabe

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).