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Validation Of Alternative Methods For Toxicity Testing
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Book Synopsis Validation of Alternative Methods for Toxicity Testing by : Chantra Eskes
Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
Book Synopsis Alternative Methods for Toxicity Testing by :
Download or read book Alternative Methods for Toxicity Testing written by and published by . This book was released on 1986 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The History of Alternative Test Methods in Toxicology by :
Download or read book The History of Alternative Test Methods in Toxicology written by and published by Academic Press. This book was released on 2018-10-20 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.
Book Synopsis Validation and Regulatory Acceptance of Toxicological Test Methods by : DIANE Publishing Company
Download or read book Validation and Regulatory Acceptance of Toxicological Test Methods written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1998-02 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Alternatives for Dermal Toxicity Testing by : Chantra Eskes
Download or read book Alternatives for Dermal Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2017-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides comprehensive information on the alternative (non-animal) dermal toxicity test methods currently available for industrial, regulatory, and academic use and also explores potential future developments. It encompasses all areas of dermal toxicity, including skin irritation, skin corrosion, skin sensitization, UV-induced effects, and skin genotoxicity. An individual chapter is devoted to each test method, with coverage of the scientific basis, validation status and regulatory acceptance, applications and limitations, available protocols, and potential role within testing strategies. In addition, perspectives from the test developer are presented, for example regarding critical steps in the protocol. The closing section addresses areas that may be of relevance for the future of dermal toxicity safety testing, including the validation and regulatory acceptance of integrated testing strategies, novel complex skin models, and high-throughput screening techniques.
Book Synopsis Toxicity Testing for Assessment of Environmental Agents by : National Research Council
Download or read book Toxicity Testing for Assessment of Environmental Agents written by National Research Council and published by National Academies Press. This book was released on 2006-04-07 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Alternative Methods for Toxicity Testing by : United States Environmental Protection Agency (EPA)
Download or read book Alternative Methods for Toxicity Testing written by United States Environmental Protection Agency (EPA) and published by Createspace Independent Publishing Platform. This book was released on 2018-07-10 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Alternative Methods for Toxicity Testing: Regulatory Policy Issues
Book Synopsis Alternative Toxicological Methods by : Harry Salem
Download or read book Alternative Toxicological Methods written by Harry Salem and published by CRC Press. This book was released on 2003-03-26 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bringing together the recent and relevant contributions of over 125 scientists from industry, government, and academia in North America and Western Europe, Alternative Toxicological Methods explores the development and validation of replacement, reduction, and refinement alternatives (the 3Rs) to animal testing. Internationally recognized scientist
Book Synopsis Reducing, Refining and Replacing the Use of Animals in Toxicity Testing by : David G. Allen
Download or read book Reducing, Refining and Replacing the Use of Animals in Toxicity Testing written by David G. Allen and published by Royal Society of Chemistry. This book was released on 2013 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This thought-provoking book describes the ever-expanding "toolbox" of methods now available to reduce, refine, or replace animal usage in toxicity testing.
Book Synopsis Toxicity Testing in the 21st Century by : National Research Council
Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-11-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Alternatives to Animal Testing by : Hajime Kojima
Download or read book Alternatives to Animal Testing written by Hajime Kojima and published by Springer. This book was released on 2018-12-27 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.
Book Synopsis Science, Medicine, and Animals by : National Research Council
Download or read book Science, Medicine, and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.
Book Synopsis Toxicity Assessment Alternatives by : Harry Salem
Download or read book Toxicity Assessment Alternatives written by Harry Salem and published by Springer Science & Business Media. This book was released on 1999-07-02 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicity Assessment Alternatives: Methods, Issues, Opportunities contains a broad array of critical surveys, contributed by active and respected investigators, describing their research and offering updates on toxicity assessment alternatives, directions determined by current and future grant programs, opportunities for mechanistically based test methods to detect endocrine disruptor activity, the use of alternatives in the Department of Defense hazard assessment initiatives, and the issues and opportunities for validation and regulatory acceptance. Several of these advances make use oftransgenic models that reduce the time and cost of carcinogenicity testing. Others use tissue cultures for the assessment of endocrine disrupting chemicals. Cultures of human epidermal keratinocytes are applicable as models for sulfur mustard lesions, and in vitro protein denaturation is used as a chemical test for assessing the ocular and dermal irritation potential of cosmetic prod ucts. Molecular modeling is applied to explaining chemical toxicity. Commercially developed assay systems have undergone extensive evaluation by their manufacturers. Some of these await external valida tion, and others await acceptance by North American and European regulatory agencies. Toxicity Assessment Alternatives: Methods, Issues, Opportunities provides information from members of the scientific and regulatory communities on what has been achieved and what has been accepted in alternatives to animal testing.
Book Synopsis Alternatives to Animal Testing by : Michael Balls
Download or read book Alternatives to Animal Testing written by Michael Balls and published by Royal Society of Chemistry. This book was released on 2006 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal experimentation has long been a controversial issue with impassioned arguments on both sides of the debate. Increasingly it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics include; the safety evaluation of chemicals, international validation and barriers to the validation of alternative tests, in vitro testing for endocrine disruptors, intelligent approaches to safety evaluation of chemicals, alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetic industries.
Book Synopsis Toxicogenomics-Based Cellular Models by : Jos Kleinjans
Download or read book Toxicogenomics-Based Cellular Models written by Jos Kleinjans and published by Academic Press. This book was released on 2014-01-02 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicogenomics-Based Cellular Models is a unique and valuable reference for all academic and professional researchers employing toxicogenomic methods with respect to animal testing for chemical safety. This resource offers cutting-edge information on the application of toxicogenomics to developing alternatives to current animal toxicity tests. By illustrating the development of toxicogenomics-based cellular models for critical endpoints of toxicity and providing real-world examples for validation and data analysis, this book provides an assessment of the current state of the field, as well as opportunities and challenges for the future. Written by renowned international toxicological experts, this book explores ‘omics technology for developing new assays for toxicity testing and safety assessment and provides the reader with a focused examination of alternative means to animal testing. Describes the state-of-the-art in developing toxicogenomics-based cellular models for chemical-induced carcinogenicity, immunotoxicity, developmental toxicity, neurotoxicity and reproduction toxicity Illustrates how to validate toxicogenomics-based alternative test models and provides an outlook to societal and economic implementation of these novel assays Includes an overview of current testing methods and risk assessment frameworks Provides a real-world assessment by articulating the current development and challenges in toxicogenomics while suggesting ways to move this field forward
Book Synopsis Validation and Regulatory Acceptance of Toxicological Test Methods by : Errol Zeiger
Download or read book Validation and Regulatory Acceptance of Toxicological Test Methods written by Errol Zeiger and published by . This book was released on 1998-04 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report was developed to recommend criteria & processes for validation & regulatory acceptance of toxicological testing methods that would be useful to Federal agencies & the scientific community. The specific goals of the report include: communicating the criteria & procedures to employ in considering new & revised test methods; encouraging the development, validation, & evaluation of new & revised test methods; contributing to regulatory acceptance & encouraging the use of valid new & revised test methods, & encouraging the reduction & refinement of animal use in testing.
Book Synopsis Principles of Toxicology Testing, Second Edition by : Frank A Barile
Download or read book Principles of Toxicology Testing, Second Edition written by Frank A Barile and published by CRC Press. This book was released on 2013-04-02 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
