ハシェク＆ルソー毒性病理学ハンドブック（第４版・全５巻）第２巻：安全性評価における毒性病理学 Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2: Safety Assessment and Toxicologic Pathology（4）

著者名：Haschek BVSc, PhD, DACVP, FIATP, Wanda M. (EDT)/Rousseaux BVSc [Hons], PhD, DABT, FRCPath, FIATP, FATS, Coli/Wallig DVM, PhD, DACVP, Matthew A. (EDT)/Bolon DVM, MS, PhD, SACVP, DABT, FATS, FIATP, Brad (EDT)

Academic Press（2023/02/18発売）

• 言語：ENG
• ISBN：9780128210475
• eISBN：9780323910521

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.- Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field- New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity- Chapters dealing with product-specific practices address pathology and regulatory issues- Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts- Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts

Table of Contents

Part 1. Product Discovery and Development1. Overview of Drug Development2. Overview of the Role of Pathology in Product Discovery and Development3. Discovery Toxicology and Discovery Pathology4. Pathology in Nonclinical Drug Safety Assessment5. Carcinogenicity AssessmentPart 2. Product-Specific Practices for Safety Assessment6. Protein Therapeutics7. Nucleic Acid Pharmaceutical Agents8. Gene Therapy and Gene Editing9. Vaccines10. Stem Cells and Other Cell TherapiesPart 3: Data Interpretation and Communication11. Biomedical Materials and Devices12. Safety Assessment of Agricultural and Bulk Chemicals13. Preparation of the Anatomic Pathology Report for Toxicity Studies14. Interpretation of Clinical Pathology Results in Nonclinical Toxicity Testing15. Assigning Adversity to Toxicologic Outcomes16. Risk Assessment17. Risk Management and Communication: Building Trust and Credibility with the Public