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Author: Alok Dhawan
Publisher: Humana Press
ISBN: 9781627035286
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Alok Dhawan
Publisher: Humana Press
ISBN: 9781627035286
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Albert P. Li
Publisher: CRC Press
ISBN: 9780849388156
Category : Medical
Languages : en
Pages : 508
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Book Description
Genetic Toxicology is a comprehensive book covering the historical perspective of genetic toxicology; basic mechanisms of mutations and chromosomal effects; health consequences of genetic damage, including cancer and inheritable mutations; properties of physical, chemical, and biological mutagens; risk assessment of human exposure to genotoxicants; and the current position of some government regulatory agencies in the United States on the issues of genetic toxicology. The book will be a useful reference for students and researchers in toxicology, genetics, cancer biology, and medicine who are interested in the basic and applied principles of genetic toxicology. It will also benefit industrial toxicologists, products registration specialists, and government regulatory specialists with responsibility for the safety evaluation of industrial and environmental agents.
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455
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Book Description
This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309112982
Category : Science
Languages : en
Pages : 300
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Book Description
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.
Author: Shiv Shankar Shukla
Publisher: CRC Press
ISBN: 100019731X
Category : Science
Languages : en
Pages : 177
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Book Description
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
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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Book Description
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.
Author: Nicolay Ferrari
Publisher: John Wiley & Sons
ISBN: 1118537335
Category : Medical
Languages : en
Pages : 576
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Book Description
A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular area of pharmacology and biotech and pharma research, from the basic science behind antisense oligonucleotides chemistry, toxicology, manufacturing, to safety assessments, the design of therapeutic protocols, to clinical experience. Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence. While the idea of antisense oligonucleotides to target single genes dates back to the 1970's, most advances have taken place in recent years. The increasing number of antisense oligonucleotide programs in clinical development is a testament to the progress and understanding of pharmacologic, pharmacokinetic, and toxicologic properties as well as improvement in the delivery of oligonucleotides. This valuable book reviews the fundamentals of oligonucleotides, with a focus on antisense oligonucleotide drugs, and reports on the latest research underway worldwide. • Helps readers understand antisense molecules and their targets, biochemistry, and toxicity mechanisms, roles in disease, and applications for safety and therapeutics • Examines the principles, practices, and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides • Provides guidelines for scientists in drug design and discovery to help improve efficiency, assessment, and the success of drug candidates • Includes interdisciplinary perspectives, from academia, industry, regulatory and from the fields of pharmacology, toxicology, biology, and medicinal chemistry Oligonucleotide-Based Drugs and Therapeutics belongs on the reference shelves of chemists, pharmaceutical scientists, chemical biologists, toxicologists and other scientists working in the pharmaceutical and biotechnology industries. It will also be a valuable resource for regulatory specialists and safety assessment professionals and an important reference for academic researchers and post-graduates interested in therapeutics, antisense therapy, and oligonucleotides.
Author: Ray Proudlock
Publisher: Academic Press
ISBN: 0128010061
Category : Medical
Languages : en
Pages : 458
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Book Description
Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. - Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab - Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results - Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) - Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab
Author: OECD
Publisher: OECD Publishing
ISBN: 9264243119
Category :
Languages : en
Pages : 15
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Book Description
The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In this test, the used genetic endpoints measure mutation at hypoxanthine-guanine phosphoribosyl transferase (HPRT), and at a transgene of xanthineguanine phosphoribosyl ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264224173
Category :
Languages : en
Pages : 25
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Book Description
The in vivo alkaline single cell gel electrophoresis assay, also called alkaline Comet Assay is a method measuring DNA strand breaks in eukaryotic cells.
