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.