Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 488 Transgenic Rodent Somatic And Germ Cell Gene Mutation Assays

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.

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 ...

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.

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 ...

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

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.

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.