Test No 488 Transgenic Rodent Somatic And Germ Cell Gene Mutation Assays

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. 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 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 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.

Download or read book Handbook of Toxicology written by Michael J. Derelanko and published by CRC Press. This book was released on 2014-03-07 with total page 1022 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics r

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.

Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-01 with total page 544 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.