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Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 488 Transgenic Rodent Somatic And Germ Cell Gene Mutation Assays
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Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays by : OECD
Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays written by OECD and published by OECD Publishing. This book was released on 2022-06-30 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Test Guideline describes an in vivo assay that detects chemicals that may induce gene mutations in somatic and germ cells. In this assay, transgenic rats or mice that contain multiple copies of chromosomally integrated plasmid or phage shuttle vectors are used. The transgenes contain reporter genes for the detection of various types of mutations induced by test chemicals.
Book Synopsis Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays by : OECD
Download or read book Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays written by OECD and published by OECD Publishing. This book was released on 2011-07-28 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Test Guideline describes an in vivo assay that detects chemicals that may induce gene mutations. In this assay, transgenic rats or mice that contain multiple copies of chromosomally integrated plasmid or phage shuttle vectors are used. The ...
Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 470: Mammalian Erythrocyte Pig-a Gene Mutation Assay by : OECD
Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 470: Mammalian Erythrocyte Pig-a Gene Mutation Assay written by OECD and published by OECD Publishing. This book was released on 2022-06-30 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Test Guideline describes an in vivo erythrocyte Pig-a gene mutation assay (hereafter called the Pig-a assay) which uses an endogenous mammalian gene, the phosphatidylinositol glycan class A gene (Pig-a), as a reporter of somatic-cell gene mutation. In vivo gene mutation tests, such as the Pig-a assay, are especially relevant for assessing mutagenicity because physiological factors, such as absorption of the test chemical from the site of exposure, distribution of the test chemical throughout the test system via systemic circulation, and in vivo metabolism and DNA repair processes, all contribute to the mutagenic responses.
Book Synopsis OECD Series on Testing and Assessment Overview on genetic toxicology TGs by : OECD
Download or read book OECD Series on Testing and Assessment Overview on genetic toxicology TGs written by OECD and published by OECD Publishing. This book was released on 2017-04-13 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following a general update of the Genetic Toxicology TGs in 2015, the present Document was written to provide succinct and useful information to individuals unfamiliar with genetic toxicology testing, as well as experienced individuals wishing to obtain an overview of the recent changes that ...
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 A Practical Guide to Toxicology and Human Health Risk Assessment by : Laura Robinson
Download or read book A Practical Guide to Toxicology and Human Health Risk Assessment written by Laura Robinson and published by John Wiley & Sons. This book was released on 2018-11-05 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author's training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.
Book Synopsis Translational Toxicology and Therapeutics by : Michael D. Waters
Download or read book Translational Toxicology and Therapeutics written by Michael D. Waters and published by John Wiley & Sons. This book was released on 2018-01-04 with total page 790 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by leading research scientists, this book integrates current knowledge of toxicology and human health through coverage of environmental toxicants, genetic / epigenetic mechanisms, and carcinogenicity. Provides information on lifestyle choices that can reduce cancer risk Offers a systematic approach to identify mutagenic, developmental and reproductive toxicants Helps readers develop new animal models and tests to assess toxic impacts of mutation and cancer on human health Explains specific cellular and molecular targets of known toxicants operating through genetic and epigenetic mechanisms
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2023-01-12 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Book Synopsis Genotoxicity and Carcinogenicity Testing of Pharmaceuticals by : Michael J. Graziano
Download or read book Genotoxicity and Carcinogenicity Testing of Pharmaceuticals written by Michael J. Graziano and published by Springer. This book was released on 2015-11-02 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Book Synopsis Biomarkers in Toxicology by : Ramesh C Gupta
Download or read book Biomarkers in Toxicology written by Ramesh C Gupta and published by Academic Press. This book was released on 2019-02-13 with total page 1248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect biomarkers. Each chapter contains several references to current literature and important resources for further reading. Given this comprehensive treatment, this book is an essential reference for anyone interested in biomarkers across the scientific and biomedical fields. - Evaluates the expansive literature, providing one resource covering all aspects of toxicology biomarkers - Includes completely revised chapters, along with additional chapters on the newest developments in the field - Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure - Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation, and much more
Book Synopsis Big Data in Predictive Toxicology by : Daniel Neagu
Download or read book Big Data in Predictive Toxicology written by Daniel Neagu and published by Royal Society of Chemistry. This book was released on 2019-12-04 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rate at which toxicological data is generated is continually becoming more rapid and the volume of data generated is growing dramatically. This is due in part to advances in software solutions and cheminformatics approaches which increase the availability of open data from chemical, biological and toxicological and high throughput screening resources. However, the amplified pace and capacity of data generation achieved by these novel techniques presents challenges for organising and analysing data output. Big Data in Predictive Toxicology discusses these challenges as well as the opportunities of new techniques encountered in data science. It addresses the nature of toxicological big data, their storage, analysis and interpretation. It also details how these data can be applied in toxicity prediction, modelling and risk assessment. This title is of particular relevance to researchers and postgraduates working and studying in the fields of computational methods, applied and physical chemistry, cheminformatics, biological sciences, predictive toxicology and safety and hazard assessment.
Book Synopsis Food Safety and Human Health by : Ram Lakhan Singh
Download or read book Food Safety and Human Health written by Ram Lakhan Singh and published by Academic Press. This book was released on 2019-07-30 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite advances in hygiene, food treatment, and food processing, diseases caused by foodborne pathogens continue to constitute a worldwide public health concern. Ensuring food safety to protect public health remains a significant challenge in both developing and developed nations. Food Safety and Human Health provides a framework to manage food safety risks and assure a safe food system. Political, economic, and ecological changes have led to the re-emergence of many foodborne pathogens. The globalization of food markets, for example, has increased the challenge to manage the microbial risks. This reference will help to identify potential new approaches in the development of new microbiologically safe foods that will aid in preventing food borne illness outbreaks and provides the basic principles of food toxicology, food processing, and food safety. Food Safety and Human Health is an essential resource to help students, researchers, and industry professionals understand and address day-to-day problems regarding food contamination and safety. - Encompasses the first pedagogic treatment of the entire range of toxic compounds found naturally in foods or introduced by industrial contaminatio - Identifies areas of vital concern to consumers, such as toxicological implications of food, and human health implications of food processing - Focuses on safety aspects of genetically modified foods and the range of processing techniques along with the important food safety laws
Book Synopsis Endocrine Disruption and Human Health by : Philippa D. Darbre
Download or read book Endocrine Disruption and Human Health written by Philippa D. Darbre and published by Academic Press. This book was released on 2021-09-19 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: **Selected for Doody's Core Titles® 2024 in Endocrinology/Metabolic Disease** Updated with new and expanded chapters, Endocrine Disruption and Human Health, Second Edition provides an introduction to what endocrine disruptors are, the issues surrounding them, the source of these chemicals in the ecosystem and the mechanisms of action and assay systems. Contributions by specialists are included to discuss the varying effects of endocrine disruption on human health, and procedures for risk assessment of endocrine disruptors, and current approaches to their regulation are also covered. With new material on topics such as low-term, low dose mixtures, windows of susceptibility, epigenetics, EDCs effect on the gut microbiome, EDCs in from polluted air and oral exposures, green chemistry, and nanotechnology, the new edition of Endocrine Disruption and Human Health is a valuable and informative text for academic and clinical researchers and other health professionals approaching endocrine disruption and its effects on human health for the first time, graduate students, and advanced undergraduate students. - Provides readers with access to a range of information from the basic mechanisms and assays through to cutting-edge research investigating concerns for human health - Presents a comprehensive, translational look at all aspects of endocrine disruption and its effects on human health - Offers guidance on the risk assessment of endocrine disruptors and current relevant regulatory considerations - Newly added content on topics like low-term, low dose mixtures, windows of susceptibility to EDCs, EDCs effect on the gut microbiome, green chemistry, and nanotechnology
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 585 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 Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 471: Bacterial Reverse Mutation Test by : OECD
Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 471: Bacterial Reverse Mutation Test written by OECD and published by OECD Publishing. This book was released on 1997-07-21 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ...
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.
