Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2: Safety Assessment and Toxicologic Pathology

ISBN-13: 9780128210475 / Angielski / Twarda / 2023

Colin G. Rousseaux; Matthew A. Wallig; Brad Bolon

Spis treści

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 Cells and Other Cell Therapies

Part 3: Data Interpretation and Communication

11. Biomedical Materials and Devices

12. Safety Assessment of Agricultural and Bulk Chemicals

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