Scientists from both academia and industry in many countries have closely cooperated to arrive at a consensus on the descriptions of all the types of tumour and preneoplastic lesions encountered in laboratory mice. The series of fascicles should provide information and guidelines especially adapted for international use in practical toxicologic pathology. Images showing the typical appearance of the discussed lesions and references to the most recently published papers complete the information presented here.
The new 4th edition of Histopathology of Preclinical Toxicity Studies is now completely in full color and continues to describe the pathology found in drug safety studies in laboratory animals with an evidence-based discussion of the relevance of these findings to the clinical investigation of new drugs for humans. Organized according to organ systems, this revision features a thoroughly updated bibliography and discusses new drug-induced pathologies and applicable species comparisons to aid in the preclinical safety assessment of new medicines. This updated reference is essential for those involved in drug safety evaluation, including pathologists, toxicologists and pharmacologists working in corporate, government, academic and research settings. - This edition is in full color and features nearly 200 high-quality images - Provides extended commentary on the relevance of pathological findings and features a fully updated bibliography containing sources for further reading - Includes new content coverage on the commonly used transgenic animal models that are used in safety assessment, specific tumor types induced by drugs in rodents, and new drug-induced pathologies and lesions
This series of fascicles comprising an international classification of rodent tumors provides information and guidelines especially adapted for international use in practical toxicologic pathology. This is expressed particularly in the concise easy-to-use format of the narrative in all sections. Included in this classification are tumors and relevant pre-neoplastic lesions of the rat for all organ systems. The goal of this classification is to harmonize and standardize the nomenclature and diagnostic criteria to be used worldwide for regulatory purposes. The complete range of organ systems in the rat will be covered in ten fascicles, of which this volume is the fourth. This fascicle on the haematopoietic system is divided into different data-sheets, each of which represents the essential information on a particular lesion. Each data-sheet is prepared in a standard layout, always starting on a new page with a header section. The descriptions of the diagnostic features comprise the main histopathological features of the specified lesion, in the form of a concise list. Most data-sheets include at least one typical micrograph, selected from among both spontaneous and induced lesions.
Boorman's Pathology of the Rat: Reference and Atlas, Second Edition, continues its history as the most comprehensive pathology reference on rat strains for researchers across science and medicine using rat models in the laboratory. It offers readers an added emphasis on the Sprague-Dawley and Wistar rat strains that is consistent with current research across academia, government, and industry. In addition, the book provides standard diagnostic criteria, basic content on histology, histological changes that result from drug toxicity and neoplasm, pathology terminology, and four-color photographs from the NTP archive and database. With updated references and photographs, as well as coverage of all rat strains, this book is not only the standard in the field, but also an invaluable resource for toxicologists, biologists, and other scientists engaged in regulatory toxicology who must make the transition from pathology results to the promulgation of meaningful regulations. - Contains full, four color photographs from the NTP archive and database and coverage of all rat strains - Provides an organ-by-organ and system-by-system approach that presents standard diagnostic criteria and basic content on histology and histological changes - Includes comprehensive and detailed background incidence data - Presents detailed descriptive content regarding changes in rat models during research
Hayes’ Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chapters that address the advances and developments since the fifth edition, the book presents everything toxicologists and students need to know to understand hazards and mechanisms of toxicity, enabling them to better assess risk. The book begins with the four basic principles of toxicology—dose matters, people differ, everything transforms, and timing is crucial. The contributors discuss various agents of toxicity, including foodborne, solvents, crop protection chemicals, radiation, and plant and animal toxins. They examine various methods for defining and measuring toxicity in a host of areas, including genetics, carcinogenicity, toxicity in major body systems, and the environment. This new edition contains an expanded glossary reflecting significant changes in the field. New topics in this edition include: The importance of dose–response Systems toxicology Food safety The humane use and care of animals Neurotoxicology The comprehensive coverage and clear writing style make this volume an invaluable text for students and a one-stop reference for professionals.
Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.
Approximately 10 years have elapsed since the first volume of the International Life Sciences Institute (ILSI) Monographs on Pathology of Laboratory Animals, Endocrine System was completed. New information of interest to pathologists has developed at a rather remarkable pace during the intervening years. Exceptional progress has been made in the routine identification of cell products in endo crine cells. A better understanding has developed of the mechanisms involved in cell metabolism, particularly involving toxins and car cinogens. Clear concepts have developed concerning the significance of some pathologic lesions in the endocrine system and their relation to human health and risk assessment. Standardized nomenclature has developed significantly during the 1O-year period since the first volume and is being utilized on an international basis. This has resulted in significant improvement in communication of pathologic data to regulatory agencies and in scientific publications worldwide. This monograph series and others sponsored by ILSI have produced a significant effect on improved communications and the international acceptance of standardized nomenclature. In this second edition, new formats have been used where more appropriate for the subjects to be covered. In many cases, the format used in the first edition still is useful. It is still necessary to recognize the morphologic features of pathologic lesions in order to identify them precisely, an essential step toward development of new insights into pathogenetic mechanisms and their use in decisions eventually applicable to public health.
