Toxicity Testing in the 21st Century

Toxicity Testing in the 21st Century

Author: National Research Council

Publisher: National Academies Press

Published: 2007-10-05

Total Pages: 217

ISBN-13: 0309109922

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Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.


Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Author: National Research Council

Publisher: National Academies Press

Published: 2007-12-19

Total Pages: 300

ISBN-13: 0309112982

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The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new waysâ€"an effort requiring funding, interagency coordination, and data management strategies.


New Technologies for Toxicity Testing

New Technologies for Toxicity Testing

Author: Michael Balls

Publisher: Springer Science & Business Media

Published: 2012-03-22

Total Pages: 282

ISBN-13: 1461430550

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The central theme running through this volume on New Technologies for Toxicity Testing is the development and application of advanced techniques for cell and tissue culture, as well as new markers and endpoints of toxicity, as alternatives to the traditional paradigm of relying on data from laboratory animal tests to undertake labelling and risk assessment. Of course, many of the techniques and methods described in this volume are in the early stages of development, and much work will be needed to ensure their further improvement, optimisation and validation. However, we are confident that this will be achieved and that, just as with the in vitro assays that were validated and granted regulatory acceptance over the last decade, these, and many other new, advanced methods, will likewise become part of the toxicologist’s improved toolbox for coping with increasingly stringent and numerous regulatory requirements and test chemicals, while placing less reliance on traditional testing paradigms.


Pharmacokinetics and Toxicokinetic Considerations - Vol II

Pharmacokinetics and Toxicokinetic Considerations - Vol II

Author: Rakesh Kumar Tekade

Publisher: Academic Press

Published: 2022-02-05

Total Pages: 816

ISBN-13: 0323913164

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Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists. - Allows readers to systematically integrate up-to-date research findings into their laboratory work - Presents focused explorations of bioanalytical methods for bioavailability and bioequivalence assessment - Provides clinical applications of concepts


Toxicity Testing for Assessment of Environmental Agents

Toxicity Testing for Assessment of Environmental Agents

Author: National Research Council

Publisher: National Academies Press

Published: 2006-04-07

Total Pages: 270

ISBN-13: 0309164869

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Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.


A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi

Publisher: Academic Press

Published: 2012-10-18

Total Pages: 903

ISBN-13: 0123878160

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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source


Pesticides in the Diets of Infants and Children

Pesticides in the Diets of Infants and Children

Author: National Research Council

Publisher: National Academies Press

Published: 1993-02-01

Total Pages: 402

ISBN-13: 0309048753

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Many of the pesticides applied to food crops in this country are present in foods and may pose risks to human health. Current regulations are intended to protect the health of the general population by controlling pesticide use. This book explores whether the present regulatory approaches adequately protect infants and children, who may differ from adults in susceptibility and in dietary exposures to pesticide residues. The committee focuses on four major areas: Susceptibility: Are children more susceptible or less susceptible than adults to the effects of dietary exposure to pesticides? Exposure: What foods do infants and children eat, and which pesticides and how much of them are present in those foods? Is the current information on consumption and residues adequate to estimate exposure? Toxicity: Are toxicity tests in laboratory animals adequate to predict toxicity in human infants and children? Do the extent and type of toxicity of some chemicals vary by species and by age? Assessing risk: How is dietary exposure to pesticide residues associated with response? How can laboratory data on lifetime exposures of animals be used to derive meaningful estimates of risk to children? Does risk accumulate more rapidly during the early years of life? This book will be of interest to policymakers, administrators of research in the public and private sectors, toxicologists, pediatricians and other health professionals, and the pesticide industry.


Environmental Neurotoxicology

Environmental Neurotoxicology

Author: National Research Council

Publisher: National Academies Press

Published: 1992-02-01

Total Pages: 167

ISBN-13: 0309045312

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Scientists agree that exposure to toxic agents in the environment can cause neurological and psychiatric illnesses ranging from headaches and depression to syndromes resembling parkinsonism. It can even result in death at high exposure levels. The emergence of subclinical neurotoxicity-the concept that long-term impairments can escape clinical detection-makes the need for risk assessment even more critical. This volume paves the way toward definitive solutions, presenting the current consensus on risk assessment and environmental toxicants and offering specific recommendations. The book covers: The biologic basis of neurotoxicity. Progress in the application of biologic markers. Reviews of a wide range of in vitro and in vivo testing techniques. The use of surveillance and epidemiology to identify neurotoxic hazards that escape premarket screening. Research needs. This volume will be an important resource for policymakers, health specialists, researchers, and students.


Scientific Frontiers in Developmental Toxicology and Risk Assessment

Scientific Frontiers in Developmental Toxicology and Risk Assessment

Author: National Research Council

Publisher: National Academies Press

Published: 2000-12-21

Total Pages: 348

ISBN-13: 0309070864

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Scientific Frontiers in Developmental Toxicology and Risk Assessment reviews advances made during the last 10-15 years in fields such as developmental biology, molecular biology, and genetics. It describes a novel approach for how these advances might be used in combination with existing methodologies to further the understanding of mechanisms of developmental toxicity, to improve the assessment of chemicals for their ability to cause developmental toxicity, and to improve risk assessment for developmental defects. For example, based on the recent advances, even the smallest, simplest laboratory animals such as the fruit fly, roundworm, and zebrafish might be able to serve as developmental toxicological models for human biological systems. Use of such organisms might allow for rapid and inexpensive testing of large numbers of chemicals for their potential to cause developmental toxicity; presently, there are little or no developmental toxicity data available for the majority of natural and manufactured chemicals in use. This new approach to developmental toxicology and risk assessment will require simultaneous research on several fronts by experts from multiple scientific disciplines, including developmental toxicologists, developmental biologists, geneticists, epidemiologists, and biostatisticians.