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Development And Applications Of Mutagenicity And Carcinogenicity Bioassays For Human Health Risk Assessment
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Book Synopsis Mutagenic Impurities by : Andrew Teasdale
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
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 Carcinogens and Anticarcinogens in the Human Diet by : National Research Council
Download or read book Carcinogens and Anticarcinogens in the Human Diet written by National Research Council and published by National Academies Press. This book was released on 1996-03-12 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite increasing knowledge of human nutrition, the dietary contribution to cancer remains a troubling question. Carcinogens and Anticarcinogens assembles the best available information on the magnitude of potential cancer riskâ€"and potential anticarcinogenic effectâ€"from naturally occurring chemicals compared with risk from synthetic chemical constituents. The committee draws important conclusions about diet and cancer, including the carcinogenic role of excess calories and fat, the anticarcinogenic benefit of fiber and other substances, and the impact of food additive regulation. The book offers recommendations for epidemiological and diet research. Carcinogens and Anticarcinogens provides a readable overview of issues and addresses critical questions: Does diet contribute to an appreciable proportion of human cancer? Are there significant interactions between carcinogens and anticarcinogens in the diet? The volume discusses the mechanisms of carcinogenic and anticarcinogenic properties and considers whether techniques used to evaluate the carcinogenic potential of synthetics can be used with naturally occurring chemicals. The committee provides criteria for prioritizing the vast number of substances that need to be tested. Carcinogens and Anticarcinogens clarifies the issues and sets the direction for further investigations into diet and cancer. This volume will be of interest to anyone involved in food and health issues: policymakers, regulators, researchers, nutrition professionals, and health advocates.
Book Synopsis Issues in Risk Assessment by : National Research Council
Download or read book Issues in Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume. The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures. The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.
Book Synopsis Science and Decisions by : National Research Council
Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
Book Synopsis Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment by : National Research Council
Download or read book Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2007-12-19 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Risk Assessment in the Federal Government by : National Research Council
Download or read book Risk Assessment in the Federal Government written by National Research Council and published by National Academies Press. This book was released on 1983-02-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.
Book Synopsis Science and Judgment in Risk Assessment by : National Research Council
Download or read book Science and Judgment in Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 1994-01-01 with total page 668 pages. Available in PDF, EPUB and Kindle. Book excerpt: The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.
Book Synopsis Robustness in Statistics by : Robert L. Launer
Download or read book Robustness in Statistics written by Robert L. Launer and published by Academic Press. This book was released on 2014-05-12 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: Robustness in Statistics contains the proceedings of a Workshop on Robustness in Statistics held on April 11-12, 1978, at the Army Research Office in Research Triangle Park, North Carolina. The papers review the state of the art in statistical robustness and cover topics ranging from robust estimation to the robustness of residual displays and robust smoothing. The application of robust regression to trajectory data reduction is also discussed. Comprised of 14 chapters, this book begins with an introduction to robust estimation, paying particular attention to iteration schemes and error structure of estimators. Sensitivity and influence curves as well as their connection with jackknife estimates are described. The reader is then introduced to a simple analog of trimmed means that can be used for studying residuals from a robust point-of-view; a class of robust estimators (called P-estimators) based on the location and scale-invariant Pitman estimators of location; and robust estimation in the presence of outliers. Subsequent chapters deal with robust regression and its use to reduce trajectory data; tests for censoring of extreme values, especially when population distributions are incompletely defined; and robust estimation for time series autoregressions. This monograph should be of interest to mathematicians and statisticians.
Book Synopsis Fluoride in Drinking Water by : National Research Council
Download or read book Fluoride in Drinking Water written by National Research Council and published by National Academies Press. This book was released on 2007-01-22 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most people associate fluoride with the practice of intentionally adding fluoride to public drinking water supplies for the prevention of tooth decay. However, fluoride can also enter public water systems from natural sources, including runoff from the weathering of fluoride-containing rocks and soils and leaching from soil into groundwater. Fluoride pollution from various industrial emissions can also contaminate water supplies. In a few areas of the United States fluoride concentrations in water are much higher than normal, mostly from natural sources. Fluoride is one of the drinking water contaminants regulated by the U.S. Environmental Protection Agency (EPA) because it can occur at these toxic levels. In 1986, the EPA established a maximum allowable concentration for fluoride in drinking water of 4 milligrams per liter, a guideline designed to prevent the public from being exposed to harmful levels of fluoride. Fluoride in Drinking Water reviews research on various health effects from exposure to fluoride, including studies conducted in the last 10 years.
Author :United States. Congress. Office of Technology Assessment Publisher :Marcel Dekker Incorporated ISBN 13 :9780824780708 Total Pages :249 pages Book Rating :4.7/5 (87 download)
Book Synopsis Identifying and Regulating Carcinogens by : United States. Congress. Office of Technology Assessment
Download or read book Identifying and Regulating Carcinogens written by United States. Congress. Office of Technology Assessment and published by Marcel Dekker Incorporated. This book was released on 1989 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: A background paper requested by the House Government Operations Committee and its subcommittee on Intergovernmental Relations and Human Resources. Describes policies issued by agencies of the US government concerning the identification, assessment, and regulation of carcinogenic chemicals; the chemicals that have been regulated because of carcinogenic risk; the US government's carcinogenicity testing program; and the Office of Technology Assessment's analysis of the extent of agency action on chemicals determined to be carcinogenic. No index. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)
Book Synopsis Toxicological Profile for 1,2-dibromoethane by :
Download or read book Toxicological Profile for 1,2-dibromoethane written by and published by . This book was released on 1992 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Toxicological Profile for N-nitrosodimethylamine by :
Download or read book Toxicological Profile for N-nitrosodimethylamine written by and published by . This book was released on 1989 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Toxicological Profile for Isophorone by :
Download or read book Toxicological Profile for Isophorone written by and published by . This book was released on 1989 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals by : National Research Council
Download or read book Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals written by National Research Council and published by National Academies Press. This book was released on 2001-06-25 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals contains a detailed and comprehensive methodology for developing acute exposure guideline levels (AEGLs) for toxic substances from inhalation exposures. The book provides guidance on what documents and databases to use, toxicity endpoints that need to be evaluated, dosimetry corrections from animal to human exposures, selection of appropriate uncertainty factors to address the variability between animals and humans and within the human population, selection of modifying factors to address data deficiencies, time scaling, and quantitative cancer risk assessment. It also contains an example of a summary of a technical support document and an example of AEGL derivation. This book will be useful to persons in the derivation of levels from other exposure routesâ€"both oral and dermalâ€"as well as risk assessors in the government, academe, and private industry.
Author :Sponsored by The Health Effects Institute Publisher :National Academies Press ISBN 13 :0309037263 Total Pages :703 pages Book Rating :4.3/5 (9 download)
Book Synopsis Air Pollution, the Automobile, and Public Health by : Sponsored by The Health Effects Institute
Download or read book Air Pollution, the Automobile, and Public Health written by Sponsored by The Health Effects Institute and published by National Academies Press. This book was released on 1988-01-01 with total page 703 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The combination of scientific and institutional integrity represented by this book is unusual. It should be a model for future endeavors to help quantify environmental risk as a basis for good decisionmaking." â€"William D. Ruckelshaus, from the foreword. This volume, prepared under the auspices of the Health Effects Institute, an independent research organization created and funded jointly by the Environmental Protection Agency and the automobile industry, brings together experts on atmospheric exposure and on the biological effects of toxic substances to examine what is knownâ€"and not knownâ€"about the human health risks of automotive emissions.
Author :National Research Council (U.S.). Committee on Diet, Nutrition, and Cancer Publisher : ISBN 13 : Total Pages :478 pages Book Rating :4.:/5 (19 download)
Book Synopsis Diet, Nutrition, and Cancer by : National Research Council (U.S.). Committee on Diet, Nutrition, and Cancer
Download or read book Diet, Nutrition, and Cancer written by National Research Council (U.S.). Committee on Diet, Nutrition, and Cancer and published by . This book was released on 1982 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt:
