[PDF] Regulatory Toxicology eBook

Author : Franz-Xaver Reichl
Publisher : Springer
Page : 0 pages
File Size : 42,32 MB
Release : 2014-03-27
Category : Medical
ISBN : 9783642353734

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This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.

Author : Shayne C. Gad
Publisher : CRC Press
Page : 311 pages
File Size : 48,35 MB
Release : 2018-09-03
Category : Medical
ISBN : 0429876513

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This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require. Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California’s Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.

Author : Shayne C. Gad
Publisher : CRC Press
Page : 424 pages
File Size : 13,40 MB
Release : 2001-07-19
Category : Medical
ISBN : 9781420025187

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This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.

Author : Tim Marrs
Publisher : Royal Society of Chemistry
Page : 638 pages
File Size : 23,56 MB
Release : 2018-02-21
Category : Medical
ISBN : 1788014049

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Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.

Author : Ali S. Faqi
Publisher : Academic Press
Page : 988 pages
File Size : 12,77 MB
Release : 2016-11-03
Category : Medical
ISBN : 0128036214

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Author : Ali S. Faqi
Publisher : Academic Press
Page : 904 pages
File Size : 47,79 MB
Release : 2012-11-02
Category : Business & Economics
ISBN : 0123878152

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A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --

Author : Timothy T. Marrs
Publisher : John Wiley & Sons
Page : 586 pages
File Size : 12,80 MB
Release : 2004-02-13
Category : Medical
ISBN : 9780471496441

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Dieser Band gehört zur bekannten Wiley-Reihe 'Current Toxicology Series' und befasst sich ausführlich mit der Pestizidtoxikologie. Untersucht werden Pestizide nach Gruppen (z. B. Insektizide und Fungizide), ihre Rückstände in Lebensmitteln sowie die Metabolisierung von Pestiziden. Darüber hinaus werden berufsbezogene Aspekte und die Behandlung von Vergiftungserscheinungen umfassend diskutiert. "Pesticide Toxicology" ist das erste einbändige Werk zum Thema Pestizide, das spezialisierte und dennoch umfassende Informationen sowohl für Experten als auch für Doktoranden bereit hält. Herausgeber Timothy Marrs ist ein international anerkannter Experte in der Pestizidforschung und genießt großes Ansehen auf dem Gebiet der Toxikologie. Geschrieben wurde der Band von einem Team international renommierterToxikologen.

Author : Hans Marquardt
Publisher : Academic Press
Page : 1355 pages
File Size : 39,3 MB
Release : 1999-10-05
Category : Medical
ISBN : 0080543111

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Toxicology is a comprehensive text for researchers and graduate students in toxicology and public health. It addresses every aspect of the field, starting with the fundamentals and incorporating such areas as organ toxicology, applications, and environmental toxicology. In addition to covering the traditional subject matter of toxicology, special emphasis has been placed on recent areas of interest, such as risk assessment, apoptosis, and methodical developments. Key Features * Comprehensive text, covering all aspects of the field of toxicology * Analyzes the importance of toxicokinetics and metabolism as well as cellular targets for the mechanisms of toxic effects * Identifies the various classes of chemical compounds responsible for the toxic effects * Describes the approaches and methods used by various disciplines which investigate toxic effects and their prevention * Adapted from a very successful German text, this edition is completely revised and expanded * The text is well illustrated with diagrams, charts, and tables

Author : Christopher P. Chengelis
Publisher :
Page : 398 pages
File Size : 48,4 MB
Release : 2001
Category : Chemicals
ISBN : 9780203280270

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This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individua.