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Author: Anna Bal-Price
Publisher: Humana
ISBN: 9781493954803
Category : Medical
Languages : en
Pages : 0
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Book Description
In Vitro Toxicology Systems brings together important issues and considerations needed in order to develop a workable, reliable, integrated testing strategy for the replacement of animals in toxicity testing regimes. This thorough volume includes sections on in vitro models for systemic organ toxicity, neurotoxicity, sensory organs, immunotoxicity and reproductive toxicity and addresses how stem cells may be used going forward. The book also tackles difficult areas of toxicology such as carcinogenicity and nanotoxicology, with additional chapters dedicated to kinetics, metabolism, and in vitro in vivo extrapolation. The book also addresses biological processes such as stress response pathways and mechanistic biomarkers and how these can be uncovered and measured using high content approaches. Reliable and authoritative, In Vitro Toxicology Systems will be of benefit not only to students, scientists and regulators working in the field of chemical safety assessment but also to a wider scientific audience.
Author: Anna Bal-Price
Publisher: Humana
ISBN: 9781493954803
Category : Medical
Languages : en
Pages : 0
Get Book Here
Book Description
In Vitro Toxicology Systems brings together important issues and considerations needed in order to develop a workable, reliable, integrated testing strategy for the replacement of animals in toxicity testing regimes. This thorough volume includes sections on in vitro models for systemic organ toxicity, neurotoxicity, sensory organs, immunotoxicity and reproductive toxicity and addresses how stem cells may be used going forward. The book also tackles difficult areas of toxicology such as carcinogenicity and nanotoxicology, with additional chapters dedicated to kinetics, metabolism, and in vitro in vivo extrapolation. The book also addresses biological processes such as stress response pathways and mechanistic biomarkers and how these can be uncovered and measured using high content approaches. Reliable and authoritative, In Vitro Toxicology Systems will be of benefit not only to students, scientists and regulators working in the field of chemical safety assessment but also to a wider scientific audience.
Author: Donald J. Ecobichon
Publisher: CRC Press
ISBN: 9780849385544
Category : Medical
Languages : en
Pages : 240
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Book Description
This substantially updated edition presents fundamental principles and concepts behind the various types of toxicological studies, and explains how to design and conduct studies and interpret results. The text explains the increasing need to monitor, assess, and reevaluate the toxicity database of many agents and evaluates the place of individual studies in the overall toxicological assessment of a chemical. Concise descriptions of the formats of in vivo and in vitro studies and methods used in assessing endpoints of toxicity make this an essential introduction and guide for anyone who needs to understand or conduct toxicological studies. Reflecting increasing interest in the "Three Rs" (Reducing, Refining, and Replacement of existing animal tests) in recent years, the Second Edition includes much more information on a variety of new alternative testing protocols. Particular attention is given to the new in vitro alternative testing procedures being incorporated into EEC regulations. The text also covers studies required by regulatory agencies around the world.
Author: Frank A Barile
Publisher: CRC Press
ISBN: 1842145282
Category : Medical
Languages : en
Pages : 368
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Book Description
Nationally, toxicology programs have evolved from a traditional exploration of the chemistry and applied toxicity of chemicals and drugs to a more comprehensive study of toxicology and toxicology testing as independent entities. Consequently, the second edition of Principles of Toxicology Testing starts with basic toxicological principles, including absorption, distribution, metabolism, and elimination of toxins, including chemicals and drugs. The book then continues with animal (in vivo) and in vitro toxicology testing methods associated with toxicological analysis and preclinical drug development. As in the first edition, the book begins with an introduction into the fundamentals of toxicology (Section I) to prepare readers for the subsequent topics and continues through with a discussion of toxicokinetics and human risk assessment. This introductory material is useful in understanding the applications of toxicology testing. Section II describes the fundamental principles of toxicology testing in animals in greater detail. This section describes acute toxicity studies as well as subchronic and chronic studies performed on animals. Special emphasis is placed on study design and determination of classical indicators for acute and chronic testing, such as the LD50. The book examines other short- and long-term animal toxicity testing methodologies, including dermal, ocular, and reproductive toxicity testing. In addition, mutagenicity and carcinogenicity studies are also discussed in separate chapters. Section III introduces and discusses in vitro alternatives to animal toxicology tests. This section emphasizes cell culture methodology and cellular methods for acute systemic toxicity, target organ toxicity, and local toxicity. The contributors present the advantages and disadvantages of alternative methods. They also describe the use of high-throughput screening and its applications, the concepts of standardization and validation of in vitro techniques (especially large, organized validation efforts currently supported by US and EU regulatory agencies), and the theories supporting the development of in vitro methodologies. This second edition is a must-read for undergraduate and graduate toxicology students. Industrial and academic research centers will also find the text useful for establishing a toxicology testing laboratory.
Author: Douglas L. Arnold
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 702
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Book Description
Author: Yvonne Will
Publisher: John Wiley & Sons
ISBN: 1119053390
Category : Medical
Languages : en
Pages : 899
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Book Description
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
Author: Shayne Cox Gad
Publisher: Wiley-Interscience
ISBN: 9780470248461
Category : Medical
Languages : en
Pages : 1080
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Book Description
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
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: National Research Council
Publisher: National Academies Press
ISBN: 0309109922
Category : Nature
Languages : en
Pages : 217
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Book Description
Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918
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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author: Gunnar F. Nordberg
Publisher: Academic Press
ISBN: 0128231386
Category : Medical
Languages : en
Pages : 1054
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Book Description
Handbook on the Toxicology of Metals, Volume II: Specific Metals, Fifth Edition provides complete coverage of 38 individual metals and their compounds. This volume is the second volume of a two-volume work which emphasizes toxic effects in humans, along with discussions on the toxic effects of animals and biological systems in vitro when relevant. The book has been systematically updated with the latest studies and advances in technology. As a multidisciplinary resource that integrates both human and environmental toxicology, the book is a comprehensive and valuable reference for toxicologists, physicians, pharmacologists, and environmental scientists in the fields of environmental, occupational and public health. - Contains peer-reviewed chapters that deal with the effects of metallic elements and their compounds on biological systems with a focus on human health effects - Includes information on sources, transport, and the transformation of metals in the environment - Provides critical information on the properties, use, biological monitoring, dose-response relationships, diagnosis, treatment, and prevention of 38 metallic elements and their compounds
