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.
Table of 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 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
Authors
Wanda M. Haschek Professor Emerita, Dept of Veterinary Pathobiology, College of Veterinary Medicine, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.
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.
Colin G. Rousseaux Adjunct Professor, Department of Pathology and Laboratory Medicine, University of Ottawa Principal, Colin Rousseaux and Associates, Canada.
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.
Matthew A. Wallig Professor Emeritus, Department of Veterinary Pathobiology, College of Veterinary Medicine University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.
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.
Brad Bolon President and Pathologist, GEMpath, Inc., Longmont, Colorado, USA.
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.
