Immunotoxicology Strategies for Pharmaceutical Safety Assessment covers recently introduced systems for immunotoxicology testing and their applications.

Features:

• 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

Contents

1. Current Regulatory Expectations for Immunotoxicity Evaluation of Pharmaceuticals
2. Weight of Evidence Review: A New Strategy in Immunotoxicology
3. Nonclinical Core Immunotoxicity Testing in Drug Development
4. Extended Immunotoxicology Assessment: Ex Vivo Models
5. Extended Immunotoxicology Assessment: In Vivo Models
6. Immunotoxicity Testing in Biopharmaceutical Development
7. Testing for Drug Hypersensitivity
8. Testing for Developmental Immunotoxicity
9. New Methods in Assessing Immunomodulation, Immunotoxicity and Immunogenicity
10. Bridging Immunotoxicology to Clinical Drug Development

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