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Validation And Regulatory Acceptance Of Toxicological Test Methods
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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 Validation and Regulatory Acceptance of Toxicological Test Methods by :
Download or read book Validation and Regulatory Acceptance of Toxicological Test Methods written by and published by . This book was released on 1997 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 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 NTP Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods by : Kenneth Olden
Download or read book NTP Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods written by Kenneth Olden and published by . This book was released on 1997-02 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the NTP Workshop on Validation & Regulatory Acceptance of Alternative Toxicological Test Methods was to receive comments & recommendations from the public & invited experts on their draft report. It provided recommended criteria & processes for the validation & regulatory acceptance of new & revised toxicological testing methods. This report is a summary of the recommend. developed by the workshop participants. One of the goals of the NTP is developing & validating improved alternative toxicological test methods. The NTP Revit. Act directed NIEHS to: establish criteria for the validation & regulatory acceptance of alternative testing methods: & to recommend a process through which scientifically validated alternative methods can be accepted for regulatory use.
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.
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 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 Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel
Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Book Synopsis New Technologies for Toxicity Testing by : Michael Balls
Download or read book New Technologies for Toxicity Testing written by Michael Balls and published by Springer. This book was released on 2012-03-12 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis In-Vitro Toxicity Testing by : John M. Frazier
Download or read book In-Vitro Toxicity Testing written by John M. Frazier and published by CRC Press. This book was released on 1992-01-31 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on the potential application of in vitro procedures to identify and quantify the toxicological risk to target organs associated with the use of commerical products and therapeutic drugs.;Revealing how the results of in vitro toxicity testing can be used in safety assessment, In Vitro Toxicity Testing: explores whether existing test methods can accomplish the necessary goals and, if not, what research is needed to make these techniques a practical reality; presents the current status of toxicity testing in the areas of hepatotoxicity, renal toxicity, ocular irritation, and many others; outlines the role of validation in technology transfer from the research laboratory to safety evaluation; examines testing strategies and regulatory acceptance and addresses common concerns about the ultimate utilization of available methods in chemical safety/hazard considerations; and analyzes the perspective of industrial and regulatory agencies on the application of in vitro toxicity testing.;Generously referenced with over 1400 literature citations, In Vitro Toxicity Testing is for academic, industrial, and regulatory toxicologists; applied, molecular, and cell biologists; pharmacologists; animal welfare activists; and graduate students in pharmacology and toxicology courses.
Book Synopsis Principles of Toxicology Testing by : Frank A. Barile
Download or read book Principles of Toxicology Testing written by Frank A. Barile and published by CRC Press. This book was released on 2007-07-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The evolution of toxicology testing finds its impetus in the continuing growth of the chemical and pharmaceutical industries, as well as the awareness of public health initiatives, needs, and responses that demand faster, more accurate, more economical methods for screening potential toxicity. Concurrent advances in biotechnology enable viable in vitro systems to compliment traditional animal toxicology testing methods. Today, both methods are often employed together in toxicological analysis, derivation of toxicity mechanisms, and pre-clinical drug development. Principles of Toxicology Testing juxtaposes the principles of animal toxicology testing with in vitro alternative methods to highlight the importance of each for interpretation of the significance and relevance of the other. Divided into three parts, the book emphasizes the universal applications of the field as a science rather than the particular steps of laboratory technique. The first part introduces the fundamentals of the toxicology, toxicokinetics, and human risk assessment. The second part details toxicology testing in animals and describes acute, subchronic, and chronic studies as well as testing for mutagenicity and carcinogenicity. Focusing on study design and determination of classical indicators, it covers short and long term methodologies including dermal, ocular, and reproductive. Presenting the advantages and disadvantages of each method, part three introduces in vitro alternative testing such as cell cultures, cellular methods for acute systemic toxicity, as well as target organ and local toxicity. The author also considers contemporary issues such as chemical exposure, high throughput screening, and the efforts of US and E.U. regulatory agencies to standardize and validate in vitro techniques. By bringing traditional and alternative testing methods into a single volume, Principles of Toxicology Testing challenges you to interpret the significance of toxicology testing results and construct a logical approach toward the ultimate purpose of testing.
Book Synopsis OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) by : OECD
Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
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 scientists present what has been accomplished thus far in developing acceptable alternatives to traditional animal toxicological assessment and provide potentially new initiatives. In over 40 chapters, the book addresses 7 themes, beginning with the validation and regulatory acceptance of alternatives in the US, the UK, and Western Europe. Then the book covers methods based on the mechanisms of eye irritation at the ocular surface, dermal toxicity testing, and assessing neurotoxicity. It also includes a case study in the use of alternatives to determine the mechanism of sulfur mustard action and discusses the role of transgenics and toxicokinetics in the development of alternative toxicity tests. Finally the book presents recent innovations in alternatives, including the use of archival data, and in silico techniques. Focusing on the science and not the politics, Alternative Toxicological Methods concisely discusses the application of state-of-the-art methods and explores cutting-edge research related to developing and validating alternatives to animal testing. This book will benefit toxicologists, cosmetic chemists, pharmacologists, experimental biologists, dermatologists, ophthalmologists, and regulatory officers in their quest for applying the 3Rs to the use of animals in toxicological testing of drug candidates, chemicals, and cosmetics.
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 Hayes' Principles and Methods of Toxicology by : A. Wallace Hayes
Download or read book Hayes' Principles and Methods of Toxicology written by A. Wallace Hayes and published by CRC Press. This book was released on 2014-10-10 with total page 2184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes' Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chap
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 2018-08-30 with total page 0 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.
