This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.
This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more - Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology
Veterinary Toxicology, 2nd edition is a unique single reference that teaches the basic principles of veterinary toxicology and builds upon these principles to offer an essential clinical resource for those practicing in the field. This reference book is thoroughly updated with new chapters and the latest coverage of topics that are essential to research veterinary toxicologists, students, professors, clinicians and environmentalists. Key areas include melamine and cyanuric acid, toxicogenomics, veterinary medical geology, toxic gases, toxicity and safety evaluation of new veterinary pharmaceuticals and much more. The 2nd edition of this popular book represents the collective wisdom of leading contributors worldwide and continues to fill an undeniable need in the literature relating to veterinary toxicology. - New chapters covering important and timely topics such as melamine and cyanuric acid, toxicogenomics, toxic gases and veterinary medical geology - Expanded look at international topics, such as epidemiology of animal poisonings, regulatory guidelines and poisonous plants in Europe - Heavily contributed book with chapters written by qualified and well-experienced authorities across all areas of veterinary toxicology - Problem solving strategies are offered for treatment as well as in-depth knowledge of the basic mechanisms of veterinary toxicology
Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.
Written by two experienced toxicology lecturers, Principles of Toxicology provides a broad-based yet in-depth introduction to this diverse subject. Comprehensive and easy-to-read, the book covers this broad and interdisciplinary field from the viewpoint of three different functional levels: molecular and cellular; physiological; and ecological and environmental. This revised second edition expands the coverage of the book while keeping the organizational format that made the first edition a bestseller. It also includes a series of brief case studies illustrating the application of toxicological principles to current issues of interest. Each and every chapter has been revised, several have been significantly rewritten, and three are entirely new. This new edition retains the extensive cross-referencing system that links all sections and enhances the integration of material. It also includes an appendix of selected toxicants that describes chemical structure and category of use. These features combine to make finding specific information quick and easy. The highly readable format and uniform, consistent presentation of information will make this the most used reference on your shelf. See what's new in the second edition:
Nationally, toxicology programs have evolved from a traditional exploration of the chemistry and applied toxicity of chemicals and drugs to a more comprehensive study of toxicology and toxicology testing as independent entities. Consequently, the second edition of Principles of Toxicology Testing starts with basic toxicological principles, including absorption, distribution, metabolism, and elimination of toxins, including chemicals and drugs. The book then continues with animal (in vivo) and in vitro toxicology testing methods associated with toxicological analysis and preclinical drug development. As in the first edition, the book begins with an introduction into the fundamentals of toxicology (Section I) to prepare readers for the subsequent topics and continues through with a discussion of toxicokinetics and human risk assessment. This introductory material is useful in understanding the applications of toxicology testing. Section II describes the fundamental principles of toxicology testing in animals in greater detail. This section describes acute toxicity studies as well as subchronic and chronic studies performed on animals. Special emphasis is placed on study design and determination of classical indicators for acute and chronic testing, such as the LD50. The book examines other short- and long-term animal toxicity testing methodologies, including dermal, ocular, and reproductive toxicity testing. In addition, mutagenicity and carcinogenicity studies are also discussed in separate chapters. Section III introduces and discusses in vitro alternatives to animal toxicology tests. This section emphasizes cell culture methodology and cellular methods for acute systemic toxicity, target organ toxicity, and local toxicity. The contributors present the advantages and disadvantages of alternative methods. They also describe the use of high-throughput screening and its applications, the concepts of standardization and validation of in vitro techniques (especially large, organized validation efforts currently supported by US and EU regulatory agencies), and the theories supporting the development of in vitro methodologies. This second edition is a must-read for undergraduate and graduate toxicology students. Industrial and academic research centers will also find the text useful for establishing a toxicology testing laboratory.
Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health.Key Features* Over 100 tables summarizing and interpreting results* Complete coverage of all major test designs and their limitations and advantages* Current status of alternative test designs and models
This is the first book to set out a full range of research strategies for evaluating the clinical practice of acupuncture. Leading acupuncturists and researchers with international reputations share their expertise. They illustrate their descriptions with practical examples of what has worked and what has not. It outlines many of the key challenges in the field. These challenges relate to the nature of acupuncture and the gap between current research evidence and the actual experiences of acupuncturists in the field. By focusing the chapters on key research questions, rather than methods, the book has a user-friendly feel. Each chapter is easily accessible with brief explanations of research designs as well as vignettes of relevant past research. The book is based on a deep understanding of acupuncture, with its inherent complexity in practice, whether based on traditional principles or more modern concepts. By incorporating a more sophisticated understanding of the field, this book details a range of strategies aiming to develop the evidence base with the utmost rigour. It is the first book on acupuncture research to take this unique view, integrating the very best of evidence-based medicine with a genuine sensitivity to the discipline of acupuncture, from its traditional and holistic roots to its more modern interpretations.
Novel Psychoactive Substances: Classification, Pharmacology and Toxicology, Second Edition provides readers with a comprehensive examination on the classification, detection, supply and availability of novel psychoactive substances, otherwise known as "legal highs." The book covers individual classes of novel psychoactive substances that have recently emerged onto the recreational drug scene and provides an overview of the pharmacology of the substance and a discussion of their associated acute and chronic harm and toxicity. This second edition addresses drugs new to the scene, with completely updated and revised chapters. Written by international experts in the field, this multi-authored book is an essential reference for scientists, clinicians, academics, and regulatory and law enforcement professionals. - Includes chapters written by international experts in the field - Presents a comprehensive overview on the classification, detection, availability and supply of novel psychoactive substances, in addition to the pharmacology and toxicology associated with the substance - Offers a single source for all interested parties working in this area, including scientists, academics, clinicians, law enforcement and regulatory agencies - Provides a full treatment of novel psychoactive substances that have recently emerged onto the recreational drug scene, including amphetamines and the synthetic cannabinoid receptors in 'spice' and 'K2'
