Main description:

Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters.

Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety.

Contents:

Part 1. Product Discovery and Development 1. Overview of Drug Development 2. Overview of the Role of Pathology in Product Discovery and Development 3. Discovery Toxicology and Discovery Pathology 4. Pathology in Nonclinical Drug Safety Assessment 5. Carcinogenicity Assessment

Part 2. Product-Specific Practices for Safety Assessment 6. Protein Therapeutics 7. Nucleic Acid Pharmaceutical Agents 8. Gene Therapy and Gene Editing 9. Vaccines 10. Stem Cell and Other Cell Therapies 11. Biomedical Materials and Devices 12. Agricultural and Bulk Chemicals

Part 3: Data Interpretation and Communication 13. Preparation of the Anatomic Pathology Report for Toxicity Studies 14. Interpretation of Clinical Pathology Results in Nonclinical Toxicity Testing 15. Assigning Adversity to Toxicologic Outcomes 16. Risk Assessment 17. Risk Management and Communication: Building Trust and Credibility with the Public