The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters). Structural chromosome ...

The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters).

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author's training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.

Tenth volume of a 40 volume series on nanoscience and nanotechnology, edited by the renowned scientist Challa S.S.R. Kumar. This handbook gives a comprehensive overview about Nanotechnology Characterization Tools for Environment, Health, and Safety. Modern applications and state-of-the-art techniques are covered and make this volume an essential reading for research scientists in academia and industry.

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Mutagenicity: Assays and Applications presents an extensive examination of the detection, assessment and future of mutagenicity, particularly as it concerns human health and the environment. Chapters focused on specific types of mutagens or testing methods for their detection collectively explore the current state of human and environmental mutagenesis, future perspectives and regulatory needs. The test procedures for measuring mutagenicity, their advantages and limitations are described with practical and procedural detail, along with their presentation and data processing aspects. It is an essential reference covering the breadth and depth of the field of mutagenicity studies and regulation. By providing both important introductory material and practical assays and applications, this book is useful to graduate students, academic and industry researchers and regulators at various stages of their careers, leading to improved risk assessment and regulation. - Presents an up-to-date and in-depth review of the current state of mutagenesis research - Draws upon the combined experience and expertise of an international group of highly respected editors and chapter authors - Provides an introduction to the concept of mutagenesis with particular consideration given to novel chemicals and materials

Principles of Tumors: A Translational Approach to Foundations, Second Edition, provides a concise summary of translational/interdisciplinary topics on the various aspects of tumors, especially abnormalities in their cells, their causes and effects on patients. Topics discussed include how genomic abnormalities in tumors may result from the actions of carcinogens and how genomic changes determine the cell biological/morphological abnormalities in tumor cell populations. In addition, the relationships between tumor cell genomics and therapeutic outcomes are described. There are also supporting appendices on general bioscience, including the principles of histology (the cells and tissues of the body), genetics, pathology, radiology and pharmacology. This book gives a thorough, detailed, yet concise account of the main bioscience, clinical and therapeutic aspects of tumors. It emphasizes the translational aspects of research into tumors with extensive discussions of interdisciplinary issues. The content in this book will be invaluable for researchers and clinicians involved in collaborative projects where it is necessary to understand fundamental issues in other branches of biomedicine. - Presents content that has been totally updated with the most recent developments of the field, including new chapters on tumor imaging exams, new surgical techniques, immunotherapy, gene therapy, and several novel therapies using natural and synthetic compounds - Presents translational approaches for every topic to improve conceptual insights for new research projects - Covers a broad range of subjects, making it easier for the reader to understand related fields - Includes diagrams for complex topics to aid in understanding for non-specialists

LOCATE FREQUENTLY USED INFORMATION EASILY AND QUICKLY Working in the laboratory or office, you use a diverse assortment of basic information to design, conduct, and interpret toxicology studies and to perform risk assessments. The Second Edition of the best-selling Handbook of Toxicology gives you the information you need in a single reference source. NEW IN THIS EDITION: Expanded coverage of inhalation toxicology, neurotoxicology, and histopathology Additional regulatory chapters dealing with pesticides, medical devices, consumer products, and world-wide notification of new chemicals Areas of toxicology missing from the first edition such as ecotoxicology and in vitro toxicology A chapter providing extensive overview of the toxicology of metals Two chapters on basic male and female endocrinology and related toxicology Information on differences in physiological and biochemical parameters between children and adults References to Web site sources of valuable information Over 200 new tables and figures THE SINGLE SOURCE FOR THE INFORMATION YOU USE MOST FREQUENTLY Updated and expanded, this unique book includes practical reference information useful to toxicologists in the chemical and pharmaceutical industries, contract laboratories, regulatory agencies, and academia. To help you find information quickly and easily, data is arranged by toxicology subspecialty and each chapter begins with a detailed listing of information presented. Containing over 700 tables and figures, Handbook of Toxicology, Second Edition gives you a single source for the information you use most often.