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Author: Ashutosh Kumar
Publisher: Academic Press
ISBN: 0128092602
Category : Science
Languages : en
Pages : 352
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Book Description
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
Author: Ashutosh Kumar
Publisher: Academic Press
ISBN: 0128092602
Category : Science
Languages : en
Pages : 352
Get Book Here
Book Description
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
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: OECD
Publisher: OECD Publishing
ISBN: 9264122818
Category :
Languages : en
Pages : 16
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Book Description
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 ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264243178
Category :
Languages : en
Pages : 13
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Book Description
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
Author: OECD
Publisher: OECD Publishing
ISBN: 9264071245
Category :
Languages : en
Pages : 12
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Book Description
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 ...
Author: David J. Kirkland
Publisher: Cambridge University Press
ISBN: 9780521048149
Category : Medical
Languages : en
Pages : 316
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Book Description
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.
Author: S. Venitt
Publisher:
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 378
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Book Description
LABORATORY MANUAL. GENETIC TOXICOLOGY. BACTERIA. YEAST. FRUIT FLY. CULTURED MAMMALIAN CELLS. CYTOGENETIC TESTING. RODENTS. DOMINANT LETHAL TEST.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264242244
Category :
Languages : en
Pages : 25
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Book Description
This TG includes two distinct in vitro mammalian gene mutation assays requiring two specific tk heterozygous cells lines: L5178Y tk+/-3.7.2C cells for the mouse lymphoma assay (MLA) and TK6 tk+/- cells for the TK6 assay.
Author: Organisation for Economic Co-operation and Development
Publisher: Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
ISBN: 9789264122215
Category : Chemical industry
Languages : en
Pages :
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Book Description
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.
