Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals

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ISBN 13 :
Total Pages : 96 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals by : DNH & W/DOE Environmental Contaminants Advisory Committee on Mutagenesis (Canada)

Download or read book Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals written by DNH & W/DOE Environmental Contaminants Advisory Committee on Mutagenesis (Canada) and published by . This book was released on 1986 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals

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Publisher :
ISBN 13 :
Total Pages : 84 pages
Book Rating : 4.:/5 (427 download)

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Book Synopsis Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals by : Canada. Environmental Contaminants Advisory Committee on Mutagenesis

Download or read book Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals written by Canada. Environmental Contaminants Advisory Committee on Mutagenesis and published by . This book was released on 1986 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Mutagenicity: Assays and Applications

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Publisher : Academic Press
ISBN 13 : 0128092602
Total Pages : 352 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Mutagenicity: Assays and Applications by : Ashutosh Kumar

Download or read book Mutagenicity: Assays and Applications written by Ashutosh Kumar and published by Academic Press. This book was released on 2017-09-26 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mutagenicity: Assays and Applications presents an extensive examination of the detection, assessment and future of mutagenicity, particularly as it concerns human health and the environment. Chapters focused on specific types of mutagens or testing methods for their detection collectively explore the current state of human and environmental mutagenesis, future perspectives and regulatory needs. The test procedures for measuring mutagenicity, their advantages and limitations are described with practical and procedural detail, along with their presentation and data processing aspects. It is an essential reference covering the breadth and depth of the field of mutagenicity studies and regulation. By providing both important introductory material and practical assays and applications, this book is useful to graduate students, academic and industry researchers and regulators at various stages of their careers, leading to improved risk assessment and regulation. - Presents an up-to-date and in-depth review of the current state of mutagenesis research - Draws upon the combined experience and expertise of an international group of highly respected editors and chapter authors - Provides an introduction to the concept of mutagenesis with particular consideration given to novel chemicals and materials

Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards

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Publisher : Springer Science & Business Media
ISBN 13 : 3642493718
Total Pages : 200 pages
Book Rating : 4.6/5 (424 download)

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Book Synopsis Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards by : H.C. Grice

Download or read book Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards written by H.C. Grice and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Life Sciences Institute (lLSI) is a scientific foundation wh ich addresses critical health and safety issues of national and international concern. ILSI promotes international cooperation by pro viding the mechanism for scientists from government, industry and universities to work together on cooperative programs to generate and disseminate scientific data. The members and trustees of the Institute believe that questions regarding health and safety are best resolved when scientists can ex amine and discuss issues, as an independent body, se~arate from the political pressures of individual countries and the economic concerns of individual companies. Frequently, meaningful assessment of the risk of a test substance is hindered by the inherent inconsistencies in the system. The development and refinement of methods and systems to evaluate the safety of chemicals have evolved in a rapid and largely unplanned fashion. Attempts to improve the system have largely been directed toward broad general concerns, with little attention being given to specific problems or issues. A failure to resolve these problems has frequently resulted in increased testing costs and complications in the assessment and extrapolation of the results. Publicity surrounding toxicologic issues has created chronic public apprehension about the ability of science and government to deal effectively with these problems. In response to these difficulties, ILSI has assembled highly qualified and renowned scientists from research institutes, universities, government and industry, with relevant scientific knowledge and expertise regarding the issues that complicate risk assessment procedures.

Insight on Genotoxicity

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Publisher : CRC Press
ISBN 13 : 100019731X
Total Pages : 164 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis Insight on Genotoxicity by : Shiv Shankar Shukla

Download or read book Insight on Genotoxicity written by Shiv Shankar Shukla and published by CRC Press. This book was released on 2020-10-14 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development

Mutagenic Impurities

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Publisher : John Wiley & Sons
ISBN 13 : 1119551218
Total Pages : 548 pages
Book Rating : 4.1/5 (195 download)

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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.

Guidelines for the Testing of Chemicals for Toxicity

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Publisher :
ISBN 13 :
Total Pages : 74 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Guidelines for the Testing of Chemicals for Toxicity by : Great Britain. Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment

Download or read book Guidelines for the Testing of Chemicals for Toxicity written by Great Britain. Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment and published by . This book was released on 1982 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Supplementary Mutagenicity Tests

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Publisher : Cambridge University Press
ISBN 13 : 052145073X
Total Pages : 179 pages
Book Rating : 4.5/5 (214 download)

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Book Synopsis Supplementary Mutagenicity Tests by : United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing

Download or read book Supplementary Mutagenicity Tests written by United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing and published by Cambridge University Press. This book was released on 1993-11-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 1993, this volume describes supplementary tests used to assess risks of in vitro mutagenicity when basic safety tests were inconclusive.

Supplementary Mutagenicity Tests

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Publisher : Cambridge University Press
ISBN 13 : 9780521450737
Total Pages : 176 pages
Book Rating : 4.4/5 (57 download)

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Book Synopsis Supplementary Mutagenicity Tests by : David J. Kirkland

Download or read book Supplementary Mutagenicity Tests written by David J. Kirkland and published by Cambridge University Press. This book was released on 1993-11-11 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 1993, this volume describes a complementary selection of tests to those described in the companion volume Basic Mutagenicity Tests (Cambridge University Press, 1990). These supplementary tests were used to assess risks of in vitro mutagenicity in those instances where the basic tests were inconclusive. As such, these tests had an important role in the assessment of the safety of compounds, drugs and chemicals. These supplementary test and guidelines, originally drawn up by the United Kingdom Environmental Mutagen Society (UKEMS) were fully revised in this publication to take full account of different regulatory guidelines and scientific advances. This volume will be of value to anyone with aninterest in regulatory affairs, mutagenicity testing and the registration of chemical products in the UK and Europe.

Guidelines for the Testing of Chemicals for Mutagenicity

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Publisher :
ISBN 13 :
Total Pages : 112 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Guidelines for the Testing of Chemicals for Mutagenicity by : Great Britain. Committee on Mutagenicity of Chemicals in Food, Consumer Products, and the Environment

Download or read book Guidelines for the Testing of Chemicals for Mutagenicity written by Great Britain. Committee on Mutagenicity of Chemicals in Food, Consumer Products, and the Environment and published by . This book was released on 1981 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: references

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries

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Publisher : OECD Publishing
ISBN 13 : 9264078304
Total Pages : 25 pages
Book Rating : 4.2/5 (64 download)

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Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Detailed Review Document (DRD) presents an overview of classification systems/guidelines used in OECD Member countries relating to the mutagenicity of chemicals, based on responses to a questionnaire.

Genotoxicity Assessment

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Publisher : Humana Press
ISBN 13 : 9781627035286
Total Pages : 0 pages
Book Rating : 4.0/5 (352 download)

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Book Synopsis Genotoxicity Assessment by : Alok Dhawan

Download or read book Genotoxicity Assessment written by Alok Dhawan and published by Humana Press. This book was released on 2013-07-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic toxicology is recognized by geneticists and researchers concerned with the genetic impact of man-made chemicals. In Genotoxicity Assessment: Methods and Protocols, expert researchers in the field provide comprehensive genetic toxicology protocols. These include in vitro and in vivo protocols on mutation assays, cytogenetic techniques, and primary DNA damage, assays in alternate to animal models, and updated ICH guidelines. Written in the highly successful Methods in Molecular Biology series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, as well as key tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Genotoxicity Assessment: Methods and Protocols seeks to aid research students and scientists working in regulatory toxicology as well as biomedical, biochemical and pharmaceutical sciences.

Toxicological Testing Handbook

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Publisher : CRC Press
ISBN 13 : 9780824700737
Total Pages : 442 pages
Book Rating : 4.7/5 (7 download)

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Book Synopsis Toxicological Testing Handbook by : Jacobson-Kram David

Download or read book Toxicological Testing Handbook written by Jacobson-Kram David and published by CRC Press. This book was released on 2000-11-21 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to aid toxicology testing study design, this text provides data on issues such as species selection, dose level and dosing regimes, animal models, routes of exposure, statistical evaluation, data interpretation, fulfillment of regulatory requirements, and adherence to good laboratory practices.

Practical Toxicology

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Publisher : CRC Press
ISBN 13 : 149870932X
Total Pages : 778 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Practical Toxicology by : David Woolley

Download or read book Practical Toxicology written by David Woolley and published by CRC Press. This book was released on 2017-03-16 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.

Statistical Evaluation of Mutagenicity Test Data

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Publisher : Cambridge University Press
ISBN 13 : 9780521366052
Total Pages : 322 pages
Book Rating : 4.3/5 (66 download)

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Book Synopsis Statistical Evaluation of Mutagenicity Test Data by : United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing

Download or read book Statistical Evaluation of Mutagenicity Test Data written by United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing and published by Cambridge University Press. This book was released on 1989-12-07 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds.

The Assessment of Mutagenicity

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Publisher :
ISBN 13 : 9780662206248
Total Pages : 23 pages
Book Rating : 4.2/5 (62 download)

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Book Synopsis The Assessment of Mutagenicity by : Canada. Health Protection Branch

Download or read book The Assessment of Mutagenicity written by Canada. Health Protection Branch and published by . This book was released on 1993-01-01 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Health Protection Branch (HPB) Executive Committee established the Branch Genotoxicity Committee to develop recommendations on a branch-wide approach to the use of genotoxicity test results in toxicological assessment. This report, endorsed by the HPB Executive Committee, addresses the mandate under seven headings, namely: genotoxicity tests; mutagenicity testing strategy; genotoxicity tests as predictors of carcinogenicity; germ cell and somatic cell mutation; validation of genotoxicity tests; and, epidemiological extension of the regulatory process.

Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test

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Publisher : OECD Publishing
ISBN 13 : 9264243178
Total Pages : 13 pages
Book Rating : 4.2/5 (642 download)

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Book Synopsis Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test by : OECD

Download or read book Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test written by OECD and published by OECD Publishing. This book was released on 2015-07-28 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: This test measures structural chromosomal aberrations (both chromosome- and chromatid-type) in dividing spermatogonial germ cells and is, therefore, expected to be predictive of induction of heritable mutations in these germ cells