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Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 0429876513
Category : Medical
Languages : en
Pages : 311
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Book Description
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
ISBN: 0429876513
Category : Medical
Languages : en
Pages : 311
Get Book Here
Book Description
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: Franz-Xaver Reichl
Publisher: Springer
ISBN: 9783642353734
Category : Medical
Languages : en
Pages : 0
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Book Description
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
ISBN: 0429876521
Category : Medical
Languages : en
Pages : 367
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Book Description
• Describes regulatory testing requirements for all the major classes of marketed products • Explains how to prepare required documents for mandated safety testing of product • Features new chapters addressing Safety Data Sheet Preparation and Regulatory Requirements for GMOs • Covers Safety Data Sheet Preparation, which has replaced the Material Safety Data Sheet system
Author: Ronald D. Hood
Publisher: CRC Press
ISBN: 1420040545
Category : Medical
Languages : en
Pages : 1164
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Book Description
Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers e
Author: David Woolley
Publisher: CRC Press
ISBN: 1498709303
Category : Medical
Languages : en
Pages : 553
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Book Description
Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988
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Book Description
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: Shayne C. Gad
Publisher: CRC Press
ISBN: 142001420X
Category : Medical
Languages : en
Pages : 950
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Book Description
Reflecting more than a decade's worth of changes, Animal Models in Toxicology, Second Edition is a practical guide to the common statistical problems encountered in toxicology and the methodologies that are available to solve them. The book presents a historical review of the use of animal models and an overview of broad considerations of me
Author: P.J. Bert Hakkinen
Publisher: Elsevier
ISBN: 008053466X
Category : Medical
Languages : en
Pages : 953
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Book Description
Information Resources in Toxicology, Third Edition is a sourcebook for anyone who needs to know where to find toxicology information. It provides an up-to-date selective guide to a large variety of sources--books, journals, organizations, audiovisuals, internet and electronic sources, and more. For the Third Edition, the editors have selected, organized, and updated the most relevant information available. New information on grants and other funding opportunities, physical hazards, patent literature, and technical reports have also been added.This comprehensive, time-saving tool is ideal for toxicologists, pharmacologists, drug companies, testing labs, libraries, poison control centers, physicians, legal and regulatory professionals, and chemists. - Serves as an all-in-one resource for toxicology information - New edition includes information on publishers, grants and other funding opportunities, physical hazards, patent literature, and technical reports - Updated to include the latest internet and electronic sources, e-mail addresses, etc. - Provides valuable data about the new fields that have emerged within toxicological research; namely, the biochemical, cellular, molecular, and genetic aspects
Author: Ramesh C Gupta
Publisher: Elsevier
ISBN: 0080481604
Category : Medical
Languages : en
Pages : 1233
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Book Description
Veterinary Toxicology, 2nd edition is a unique single reference that teaches the basic principles of veterinary toxicology and builds upon these principles to offer an essential clinical resource for those practicing in the field. This reference book is thoroughly updated with new chapters and the latest coverage of topics that are essential to research veterinary toxicologists, students, professors, clinicians and environmentalists. Key areas include melamine and cyanuric acid, toxicogenomics, veterinary medical geology, toxic gases, toxicity and safety evaluation of new veterinary pharmaceuticals and much more. The 2nd edition of this popular book represents the collective wisdom of leading contributors worldwide and continues to fill an undeniable need in the literature relating to veterinary toxicology. - New chapters covering important and timely topics such as melamine and cyanuric acid, toxicogenomics, toxic gases and veterinary medical geology - Expanded look at international topics, such as epidemiology of animal poisonings, regulatory guidelines and poisonous plants in Europe - Heavily contributed book with chapters written by qualified and well-experienced authorities across all areas of veterinary toxicology - Problem solving strategies are offered for treatment as well as in-depth knowledge of the basic mechanisms of veterinary toxicology
Author: Frank A. Barile
Publisher: CRC Press
ISBN: 1498765386
Category : Medical
Languages : en
Pages : 623
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Book Description
As with the two previous editions, Barile’s Clinical Toxicology: Principles and Mechanisms, Third edition, examines the complex interactions associated with clinical toxicological events as a result of therapeutic drug administration or chemical exposure. With special emphasis placed on signs and symptoms of diseases and pathology caused by toxins and clinical drugs, the new edition, examines the complex interactions associated with clinical toxicological events as a result of therapeutic drug administration or chemical exposure. The new edition presents the latest, up-to-date protocols for managing various toxic ingestions, and the antidotes and treatments associated with their pathology. In addition, the effect of toxins on a limited number of body systems and drug-induced adverse drug reactions are also covered. KEY FEATURES • Discusses source of the drug or chemical, pharmacological and toxicological mechanisms of action, detection, identification, and treatment • Examines the complex interactions associated with clinical toxicological events • Emphasizes the signs and symptoms of diseases and pathology caused by toxins and clinical drugs • Covers effect of toxins on body systems and drug-induced adverse reactions • Offers a unique perspective for toxicology, pharmacology, pharmacy and health professions students The target audience for this book is undergraduate and graduate toxicology students, clinical pharmacy (Pharm.D.) students, emergency medical personnel, regulatory agencies, and other related health science professionals. It satisfies an essential need for a concise yet detailed authoritative, fundamental text addressing the current principles of clinical toxicology.
