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

4th Edition - February 18, 2023
Imprint: Academic Press
Editors: Wanda M. Haschek, Colin G. Rousseaux, Matthew A. Wallig, Brad Bolon
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 2 1 0 4 7 - 5
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 0 5 2 - 1

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… Read more

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

Purchase options

BLOOM INTO SPRING SAVINGS

Save up to 25% on books and eBooks!

Shop now

Institutional subscription on ScienceDirect

Request a sales quote

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.

Cover image
Title page
Table of Contents
Copyright
Dedication
Contributors
About the Editors
Preface
Part 1. Product Discovery and Development
Chapter 1. Overview of Drug Development
1. Introduction
2. Overview
3. Drug Discovery and Development
4. Development
5. Other Health Products
6. Clinical Trials
7. Postmarketing Surveillance
8. Regulatory Authorities
9. Summary and Conclusions
Chapter 2. Overview of the Role of Pathology in Product Discovery and Development
1. Introduction
2. Discovery Toxicology
3. Development Toxicology
4. Nonstandard Studies and End points
Chapter 3. Discovery Toxicology and Discovery Pathology
1. Introduction
2. Knowledge Integration and the Spanning of Disciplines
3. Pathology Toolbox
4. In Vitro/In Vivo Correlations
5. Target Selection
6. Target Validation
7. Translational Medicine
8. Hypothesis Generation, Experimental Design, and the Role of Investigative Studies
9. Discovery Strategy for Biologics
10. Communications
11. Personality and Behavioral Traits that Are Helpful to Succeed in Discovery Pathology and Discovery Toxicology
12. Summary
Chapter 4. Pathology in Nonclinical Drug Safety Assessment
1. Introduction
2. Drug Safety and Efficacy Are a Continuum
3. The Pathologist's Role in Nonclinical Safety Assessment
4. Pathology in Nonclinical Safety Assessment of Small Molecules
5. Pathology in Nonclinical Safety Assessment of Biotherapeutics
6. Pathology in Nonclinical Safety Assessment of Novel Formulations
7. Digital Pathology and Computational Pathology
8. Novel Investigative Tools in Nonclinical Safety Assessment
9. Conclusion
Chapter 5. Carcinogenicity Assessment
1. The Past, Present, and Potential Future of Carcinogenicity Assessment
2. Purpose, Planning, Prerequisite Information, and Timing of Lifetime Carcinogenicity Studies
3. Two-Year Rodent Carcinogenicity Studies
4. Alternative Genetically Modified Mouse Models
5. Carcinogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
6. Carcinogenicity Assessment of Nucleic Acid Therapies
7. Carcinogenicity Assessment of Stem Cell–Derived Therapies
8. Carcinogenicity Assessment of Medical Devices
9. Conclusion
Part 2. Product-Specific Practices for Safety Assessment
Chapter 6. Protein Therapeutics
1. History of Protein Therapeutics
2. Types of Protein Therapeutics: Structural and Functional Considerations
3. General Nonclinical Toxicity Testing Strategies
4. Immunogenicity
5. Off-Target Profiling
6. General Toxicity Study Design Considerations
7. Immunotoxicity
8. Safety Pharmacology Assessments
9. Developmental and Reproductive Toxicity Studies and Juvenile Animal Studies
10. Genotoxicity
11. Carcinogenicity Studies
12. Advanced Cancer
13. Antibody-Drug Conjugates
14. Multispecific Molecules
15. Biosimilars
16. Toxicologic Pathology of Protein Therapeutics—Putting It All Together
Glossary
Chapter 7. Nucleic Acid Pharmaceutical Agents
1. Introduction
2. Nucleic Acid Pharmaceuticals
3. Nucleic Acid Pharmaceutical Design and Development
4. Safety Evaluation of Nucleic Acid Pharmaceuticals
5. Conclusions
Glossary
Chapter 8. Gene Therapy and Gene Editing
1. Introduction
2. General Principles of Nonclinical Research and Development for Gene Therapy Products
3. In Vivo Gene Therapy
4. Ex Vivo Gene Therapy
5. Genome Editing
6. Conclusion
Glossary
Chapter 9. Vaccines
1. Introduction
2. Vaccine Immunology
3. General Concepts in Vaccine Toxicology
4. Vaccine Modalities
5. Vaccine Adjuvants
6. Vaccine Pharmacology and Other Studies
7. Vaccine Safety Studies
8. Vaccine Studies—Design, Technical Considerations, and Data Interpretation
9. Special Considerations for Therapeutic Modalities
10. Nonclinical Toxicity—Determining Adversity
11. Nonclinical Toxicity and Human Translation
12. Vaccines and the Anti-Vaccine Movement
13. Conclusions
14. Glossary
Chapter 10. Stem Cell and Other Cell Therapies
1. Introduction
2. Biological Principles of Cell Therapy
3. Preclinical Considerations for Cell Therapies
4. Stem Cell–Based Toxicity Testing
5. Summary
Glossary
Chapter 11. Biomedical Materials and Devices
1. Introduction
2. Definitions of Biomaterials and Biomedical Devices
3. Regulatory Guidelines
4. Safety and Functional Assessments of Biomaterials and Devices
5. Organ Systems Commonly Treated with Biomaterials/Medical Devices
6. Conclusion
Chapter 12. Safety Assessment of Agricultural and Bulk Chemicals
1. Introduction
2. Definition and Use of Agricultural Chemicals
3. Definition and Use of Bulk Chemicals
4. Safety Evaluation Strategies
5. Regulatory Studies for Registration of Agro/Bulk Chemicals
6. Toxicologic Pathology Findings and Assessment
7. Summary and Conclusions
8. Glossary
Part 3. Data Interpretation and Communication
Chapter 13. Preparation of the Anatomic Pathology Report for Toxicity Studies
1. Introduction
2. Objective and Audience for the Anatomic Pathology Report
3. Developing the Data for the Anatomic Pathology Report
4. Reversibility
5. Text Tables
6. The Anatomic Pathology Report Discussion
7. The Anatomic Pathology Report Conclusion
8. Signing the Anatomic Pathology Report
9. Examples to Be Avoided in Interpreting/Presenting Data in the Anatomic Pathology Report
10. Peer Review and Pathology Working Groups
11. Conclusion
Chapter 14. Interpretation of Clinical Pathology Results in Nonclinical Toxicity Testing
1. Introduction
2. Sample Collection
3. Hematology Interpretation (also see Hematopoetic System, Vol 5, Chap 5)
4. Interpretation of Bone Marrow Morphology
5. Coagulation Interpretation
6. Clinical Chemistry Interpretation
7. Urinalysis and Urine Chemistry Interpretation
8. Nonstandard Biomarkers
9. Potential Effects Unrelated to Test Article Treatment
10. Overall Results Interpretation and Report Integration
11. Comparator Data, Historical Controls, and Statistics
12. Descriptors and Biologic Relevance
13. Report Writing and Integration
14. Conclusions
Chapter 15. Assigning Adversity to Toxicologic Outcomes
1. Introduction and the Need for Quantifying Adversity
2. Regulatory Assessment of Adversity in the EU, the United States, and Japan
3. Adverse Reactions, Adaptation, and Reversibility
4. The Relationship Between Dose Response and Potency Thresholds in Defining Adversity
5. The Role of Pathology in Defining Adversity
6. Case Examples of Assessing Adversity
7. Guidelines for Adversity Decisions
8. New Approaches to Characterizing Adversity in the 21st Century?
9. Conclusions
Chapter 16. Risk Assessment
1. Introduction
2. Classical Risk Assessment
3. Advances in Contemporary Risk Assessment
Chapter 17. Risk Management and Communication: Building Trust and Credibility With the Public
1. Defining Risk
2. Managing Risk
3. Communicating Risk
4. Conclusions
Index

Wanda M. Haschek

Wanda M. Haschek-Hock, BVSc, Ph.D., is a Diplomate of the American College of Veterinary Pathologists (DACVP), Fellow of the International Academy of Toxicologic Pathology (FIATP), and Honorary Member of the Latin American Society of Toxicologic Pathology. She is Professor Emerita at the University of Illinois College of Veterinary Medicine, Department of Pathobiology. Wanda has over 40 years of experience in comparative, respiratory, and toxicologic pathology with a research focus on natural toxins and food safety. She is a former President of the Society of Toxicologic Pathology (STP) and of the Society of Toxicology’s (SOT) Comparative and Veterinary Specialty Section and has served as an Associate Editor for Toxicological Sciences and Toxicologic Pathology, as Councilor of the American College of Veterinary Pathologists (ACVP), and as Member of the American Board of Toxicology (ABT). She served as an Editor for the three editions of the Fundamentals of Toxicologic Pathology and Haschek and Rousseaux’s Handbook of Toxicologic Pathology. She is a recipient of the STP’s Lifetime Achievement Award, the SOT Midwest Regional Chapter’s Kenneth DuBois Award, and the University of Sydney Faculty of Veterinary Science Alumni Award for International Achievement in 2016.

Affiliations and expertise

Professor Emerita, Dept of Veterinary Pathobiology, College of Veterinary Medicine, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

Colin G. Rousseaux

Colin G. Rousseaux, BVSc, Ph.D., DABT, FIATP, is also a Fellow of the Royal College of Pathology (FRCPath) and Fellow of the Academy of Toxicological Sciences (FATS). He is a Professor (Adjunct) in the Department of Pathology and Laboratory Medicine, Faculty of Medicine, University of Ottawa, Canada. He has over 35 years of experience in comparative and toxicologic pathology with a research focus on herbal remedies, fetal development and teratology, and environmental pollutants. He has described, investigated, and evaluated numerous toxicologic pathology issues associated with pharmaceuticals, pesticides, and agrochemicals. He has served on the editorial board of Toxicologic Pathology. He is a former President of the STP. Colin served as an Editor for the three editions of the Fundamentals of Toxicologic Pathology and Haschek and Rousseaux’s Handbook of Toxicologic Pathology.

Affiliations and expertise

Adjunct Professor, Department of Pathology and Laboratory Medicine, University of Ottawa Principal, Colin Rousseaux and Associates, Canada

Matthew A. Wallig

Matthew A. Wallig, DVM, Ph.D., DACVP, is Professor Emeritus in the Department of Pathobiology, College of Veterinary Medicine, the Department of Food Science and Human Nutrition, as well as the Division of Nutritional Sciences at the University of Illinois. His research has focused on the chemoprotective properties and mechanisms of phytochemicals in the diet, in particular those in cruciferous vegetables, soy, and tomatoes. His current interests have expanded to include defining morphologic parameters for diagnostic quantitative ultrasound in pancreatitis, pancreatic and hepatic neoplasia, metastatic disease, and chronic hepatic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Matt has served as an Editor for the last two editions of the Fundamentals of Toxicologic Pathology and Haschek and Rousseaux’s Handbook of Toxicologic Pathology.

Affiliations and expertise

Professor Emeritus, Department of Veterinary Pathobiology, College of Veterinary Medicine University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

Brad Bolon

Brad Bolon, DVM, MS, Ph.D., DAVCP, DABT, FATS, FIATP, FRCPath, has worked [sic] as an experimental and toxicologic pathologist in several settings: academia, a contract research organization, pharmaceutical companies (in both biomolecule and traditional small molecule settings), and private consulting. His main professional interests are the pathology of genetically engineered mice (especially embryos, fetuses, and placentas) and toxicologic neuropathology to assess the efficacy and safety of many therapeutic entities (biomolecules, cell and gene therapies, medical devices, and small molecules). He is a former President of the STP and a Member of the American College of Toxicology (ACT), British Society of Toxicological Pathology (BSTP), and European Society of Toxicologic Pathology (ESTP). Brad served as an Editor for the third edition of the Fundamentals of Toxicologic Pathology and an Associate Editor for the third edition of Haschek and Rousseaux’s Handbook of Toxicologic Pathology.

Affiliations and expertise

President and Pathologist, GEMpath, Inc., Longmont, Colorado, USA

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

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

Purchase options

BLOOM INTO SPRING SAVINGS

Institutional subscription on ScienceDirect

Wanda M. Haschek

Colin G. Rousseaux

Matthew A. Wallig

Brad Bolon

Related books