Atlas of Histology of the Juvenile Rat should be of interest to toxicologic pathologists, toxicologists, and other biological scientists who are interested in the histomorphology of juvenile rats. For several decades the laboratory rat has been used extensively in nonclinical toxicology studies designed to detect potential human toxicity of drugs, agrochemicals, industrial chemicals, and environmental hazards. These studies traditionally have involved young adult rats that are 8-10 weeks of age as studies are started. It is becoming increasingly apparent that children and young animals may have different responses to drug/chemical exposures, therefore, regulatory agencies are emphasizing toxicology studies in juvenile animals. While the histologic features of organs from young adult and aged laboratory rats are well known, less is known about the histologic features of organs from juvenile rats. Final histologic maturity of many organs is achieved postnatally, thus immature histologic features must be distinguished from chemical- or drug-related effects. While this postnatal organ development is known to exist as a general concept, detailed information regarding postnatal histologic development is not readily available. The Atlas includes organs that are typically sampled in nonclinical toxicology studies and presents the histologic features at weekly intervals, starting at birth and extending through postnatal day 42.

Atlas of Histology of the Juvenile Rat should be of interest to toxicologic pathologists, toxicologists, and other biological scientists who are interested in the histomorphology of juvenile rats. For several decades the laboratory rat has been used extensively in nonclinical toxicology studies designed to detect potential human toxicity of drugs, agrochemicals, industrial chemicals, and environmental hazards. These studies traditionally have involved young adult rats that are 8-10 weeks of age as studies are started. It is becoming increasingly apparent that children and young animals may have different responses to drug/chemical exposures, therefore, regulatory agencies are emphasizing toxicology studies in juvenile animals. While the histologic features of organs from young adult and aged laboratory rats are well known, less is known about the histologic features of organs from juvenile rats. Final histologic maturity of many organs is achieved postnatally, thus immature histologic features must be distinguished from chemical- or drug-related effects. While this postnatal organ development is known to exist as a general concept, detailed information regarding postnatal histologic development is not readily available. The Atlas includes organs that are typically sampled in nonclinical toxicology studies and presents the histologic features at weekly intervals, starting at birth and extending through postnatal day 42. - Written and edited by highly experienced, board-certified toxicologic pathologists - Includes more than 700 high-resolution microscopic images from organs that are typically examined in safety assessment toxicology studies - Detailed figure legends and chapter narratives present the salient features of each organ at each time interval - Figures are available for further study via Elsevier's Virtual Microscope, which allows viewing of microscopic images at higher magnification - Valuable resource for toxicologic pathologists who are confronted with interpretation of lesions in juvenile rats in situations where age-matched concurrent controls are not available for comparison, e.g., with unscheduled decedents - Figures are available for further study on ScienceDirect with Virtual Microscope, which allows viewing of microscopic images at higher magnification

A Practical Guide to the Histology of the Mouse provides a full-colour atlas of mouse histology. Mouse models of disease are used extensively in biomedical research with many hundreds of new models being generated each year. Complete phenotypic analysis of all of these models can benefit from histologic review of the tissues. This book is aimed at veterinary and medical pathologists who are unfamiliar with mouse tissues and scientists who wish to evaluate their own mouse models. It provides practical guidance on the collection, sampling and analysis of mouse tissue samples in order to maximize the information that can be gained from these tissues. As well as illustrating the normal microscopic anatomy of the mouse, the book also describes and explains the common anatomic variations, artefacts associated with tissue collection and background lesions to help the scientist to distinguish these changes from experimentally- induced lesions. This will be an essential bench-side companion for researchers and practitioners looking for an accessible and well-illustrated guide to mouse pathology. Written by experienced pathologists and specifically tailored to the needs of scientists and histologists Full colour throughout Provides advice on sampling tissues, necropsy and recording data Includes common anatomic variations, background lesions and artefacts which will help non-experts understand whether histologic variations seen are part of the normal background or related to their experimental manipulation

Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.

Anatomy and Histology of the Laboratory Rat in Toxicology and Biomedical Research presents the detailed systematic anatomy of the rat, with a focus on toxicological needs. Most large works dealing with the laboratory rat provide a chapter on anatomy, but fall far short of the detailed account in this book which also focuses on the needs of toxicologists and others who use the rat as a laboratory animal. The book includes detailed guides on dissection methods and the location of specific tissues in specific organ systems. Crucially, the book includes classic illustrations from Miss H. G. Q. Rowett, along with new color photo-micrographs. Written by two of the top authors in their fields, this book can be used as a reference guide and teaching aid for students and researchers in toxicology. In addition, veterinary/medical students, researchers who utilize animals in biomedical research, and researchers in zoology, comparative anatomy, physiology and pharmacology will find this book to be a great resource. - Illustrated with over a hundred black and white and color images to assist understanding - Contains detailed descriptions and explanations to accompany all images helping with self-study - Designed for toxicologic research for people from diverse backgrounds including biochemistry, pharmacology, physiology, immunology, and general biomedical sciences

The third edition of The Laboratory Rat features updated information on a variety of topics, including rats as research models for basic and translational research in areas such as genomics, alcoholism, diabetes, metabolic syndrome, obesity, neuroscience, spinal cord injury, traumatic brain injury, regenerative medicine, and infectious disease. New information related to the husbandry and veterinary care of rats is provided including topics related to nutrition, reproduction, anesthesia and surgery, infectious and noninfectious disease, and the care of surgical and other fragile models. It is a premier source of information on the laboratory rat, this book will be of interest to veterinary and medical students, senior graduate students, postdocs and researchers who utilize animals in biomedical research. - New chapters on the care of surgical and fragile models and on the use of rats in research areas such as alcoholism, regenerative medicine, spinal cord injury, traumatic brain injury, and others are included. - All chapters were written by scientific and veterinary experts. - This book condenses information from many sources on topics related to the care and use of rats in research. - It is the premier source of information on the laboratory rat.

This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help non-pathologists understand, contextualize, and communicate the pathology data and interpretations from the study pathologist in a practical and usable format. Within the book, readers will find an overview of general pathology concepts that include fundamental vocabulary and the basics of pathophysiological processes, along with numerous chapters devoted to pathology in specific organ systems as well as topics such as biomarkers, correlation of clinical pathology endpoints (chemistry and hematology) with microscopic changes, and well-known pathology findings for classes of toxic substances. Authoritative, practical, and comprehensive, Toxicologic Pathology for Non-Pathologists aims to help non-pathologists understand, converse in, and apply a basic understanding of pathology in their day-to-day careers.

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

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 four 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 1, "Principles and the Practice of Toxicologic Pathology," covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Other volumes in this work round out the depth and breadth of coverage.Volume 2 encompasses "Toxicologic Pathology in Safety Assessment" and "Environmental Toxicologic Pathology". These two sections cover the application of toxicologic pathology in developing specific product classes, principles of data interpretation for safety assessment, and toxicologic pathology of major classes of environmental toxicants. Volumes 3 and 4 provide deep and broad treatment of "Target Organ Toxicity", emphasizing the comparative and correlative aspects of normal biology and toxicant-induced dysfunction, principal methods for toxicologic pathology evaluation, and major mechanisms of toxicity. These volumes comprise the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Each volume is being published separately. - Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology - Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology - Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

There has been an enormous growth of interest in the field of toxicologic pathology and particularly on its impact on nonclinical safety assessment in global drug development and in the environment. Toxicologic pathologists play an important role in detecting test article-related adverse effects by characterizing morphologic changes in animal tissues and/or body fluids under prescribed study conditions or less clearly defined conditions in the environment and in the interpretation of these findings relative to human risk. In fact, pathology evaluation is often the single most important decision-making factor in nonclinical safety assessments as 80% of drug candidate attrition has been attributed to pathology findings in toxicity studies. There are currently no primers or basic overviews covering the field of toxicologic pathology, whereas there are at least several basic books that cover the sister field of toxicology. Toxicologic Pathology: A Primer is a practical, easy-to-use reference designed to contain core information provided by board-certified veterinary pathologists, all experts in the field. The Primer contains the basic, underlying principles of toxicologic pathology at the introductory level; thus it will be valuable to the veterinary pathology student who may be considering a career in the field as well as a companion to the seasoned toxicologic pathologist who wants a succinct refresher. The Primer is arranged as chapters presenting each major organ system preceded by an overview chapter covering the field of toxicologic pathology followed by a “concept” chapter describing the role of toxicologic pathology in drug development. Photomicrographs and illustrations provide visual context. The organ system chapters provide histopathologic descriptions of lesions observed in toxicity studies of test articles in drug development and testing of chemicals that may negatively impact the environment. Each organ system chapter provides additional information related to a particular lesion to aid the reader in better understanding its toxicologic significance relative to human risk. Each organ system chapter contains: A brief introduction A succinct description of the anatomy and physiology of the system Descriptions of the most important pathological lesions Differential diagnoses Biological consequences, pathogenesis, and/or mechanism of lesion formation Associated clinical pathology correlates Nonclinical safety scientists such as study directors, non-pathology-oriented contributing scientists such as senior toxicology report reviewers, scientific management of Contract Research Organizations (CROs), and students should find the Primer useful in helping them understand the fundamentals of toxicologic pathology.