"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."

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.

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or kill humand and other higher organisms. Non-animals or in vitro models started to gain significant use in the 1960s. As a result of the increased concern over animal welfare, economic factors, and the need for greater sensitivity and understanding of mechanisms, interest in in vitro^n models has risen. This volume demonstrates that there now exists a broad range of in vitro models for use in either identifying or understanding most forms of toxicity. The availability of in vitro models spans both the full range of endpoints (irritation, sensitization, lethality, mutagenicity, and devlopmental toxicity) and the full spectrum of target organ systems (skin, eye, heart, liver, kidney, nervous system, etc.). Chapters are devoted to each of these speciality areas from a perspective of presenting the principal models and their uses and limitations. Chapters that overview the principles involved in the general selection and use of models, and that address the issues of safety concerns and regulatory acceptance of these methods are also included.

Since its establishment by USDA regulation in the mid-1980s, the Institutional Animal Care and Use Committee (IACUC) has evolved as the premier instrument of animal welfare oversight within research institutions in the United States. By addressing questions and problems that often confront institutions, The IACUC Handbook, Second Edition provides accurate, succinct answers. It features comprehensive updates for all pertinent federal laws, regulations, and policies. It also contains an expanded survey of IACUC practices from institutions around the nation. With accessible information, this new editionprovides a foundation for those attempting to understand and implement the many and varied responsibilities of these committees.

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.

The design of consumer products has a central role in its potential for contributing to a healthier living and working space. However, too often consumers are only aware of the designers' role when bad practice manifestly exacerbates the easy application of basic functionality. This important book places human factors perspective firmly at the centre of good practice in consumer product design, encouraging rigorous human factors evaluation and methodology as an essential component of the design process. The book's central theme is to introduce human factors techniques to consumer product design and the efficacy of the approach is illustrated with several case studies from a diverse variety of products. Products addressed range from scissors to strimers, from pens to power tools, from kettles to cookers, from radio-cassettes to rucksacks, adn from razors to VCRs. Techniques brought to bear on the devices include: checklists, hierarchical task analysis, observations, interviews, error prediction, questionnaires, guidelines, focus groups, simulations and user trials. Key Features: * Foreword by Sean Blair of the Design Council * Valuable resource for professionals, academics and students in both human factors engineering and design * Fosters an approach which integrates the skills of both professions in a successful approach to consumer product design * Includes plenty of examples throughout the book

This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require. Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California’s Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.

The lungs provide a significant opportunity for the introduction of both therapeutic and toxic chemicals into the human body. In occupational and domestic environments, hazardous chemicals can enter the body through the lungs via gases, aerosols, and particulates from natural and anthropogenic sources. Fully updated with new research and discoveries since the last edition, Inhalation Toxicology, Third Edition presents contributions from internationally recognized scientists in the academic, commercial/industrial, and governmental sectors. A pragmatic resource for practicing professionals and students, the book comprehensively examines the relationship between the respiratory system and the toxicology of inhaled substances. Topics include: Regulatory aspects of exposure and testing Testing equipment and procedures Respiratory allergy and irritation of the respiratory tract Risk assessment Toxicology theory Toxicology modeling Toxic effects of some individual toxicants New topics in this third edition include collection and characterization of airborne particulate matter, the inhalation toxicology of asbestos fibers and nanoparticles, and the development of lung-on-a-chip technology for predicting in vivo responses. Each chapter concludes with thought-provoking questions and answers, enhancing the book’s educational utility.

Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.