Regulatory Toxicology, Second Edition PDF Download

Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 9781420025187
Category : Medical
Languages : en
Pages : 424

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Book Description
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: Shayne C. Gad
Publisher: CRC Press
ISBN: 0429876513
Category : Medical
Languages : en
Pages : 322

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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: 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:
ISBN: 9780367801168
Category : BUSINESS & ECONOMICS
Languages : en
Pages : 354

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Book Description

Author: Michael J. Derelanko
Publisher: CRC Press
ISBN: 1439890137
Category : Law
Languages : en
Pages : 1027

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Book Description
The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics range from General Toxicology, to Genetic Toxicology, Human Clinical Toxicology, Histopathology, Clinical Pathology, Metabolism and Toxicokinetics, Risk Assessment, and more. New to this edition: Completely rewritten chapters covering immunotoxicology, endocrine toxicology, and reproductive and developmental toxicology, providing a fresh perspective on these topics Addition of new chapters on Chemical Toxicology, Pharmaceutical Toxicology, Juvenile Toxicology, and Safety Pharmacology Updated information dealing with Inhalation Toxicology, Neurotoxicology, and Regulatory Toxicology, which has been consolidated into single chapters for each specialty A separate glossary with toxicological terms presented both alphabetically and by toxicological subspecialty For nearly 20 years, this handbook has remained the only reference book of its kind, designed to facilitate easy access to information related to the various toxicology specialties. This updated edition of a popular reference book reflects current practices and the state of the science of toxicology.

Author: Ronald D. Hood
Publisher: CRC Press
ISBN: 1420040545
Category : Medical
Languages : en
Pages : 1168

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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 evaluating and interpreting data. Originally titled Handbook of Developmental Toxicology, the second edition's new name reflects significant changes in its content and scope. New coverage in the Second Edition: Genomics and proteomics Tests for endocrine disruptors Testing for male and female reproductive toxicity Extensive treatment of the significance, reliability, and interpretation of developmental and reproductive toxicity data Toxicity testing in neonatal and juvenile animals Postnatal developmental milestones FDA perspective on risk assessment Extensive glossaries of developmental defect terminology Previous books on this subject have largely been academically oriented and not intended to guide the practicing developmental or reproductive toxicologist. Useful and informative, this book blends the theoretical foundation with insights gained from hands-on experience. It includes tables of comparative developmental milestones - both pre- and postnatal, glossaries of descriptive terms used in developmental toxicity evaluation, and both US and international regulatory guidelines. Bridging the gap between theory and application, this is a handy single-source of essential information to use in planning, conducting, and interpreting studies.

Author: David Woolley
Publisher: CRC Press
ISBN: 149870932X
Category : Medical
Languages : en
Pages : 778

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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: Philip Wexler
Publisher: Academic Press
ISBN: 0127447709
Category : Medical
Languages : en
Pages : 953

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Book Description
History: -- K.D. Watson, P. Wexler, and J. Everitt. -- Highlights in the History of Toxicology. -- Selected References in the History of Toxicology. -- A Historical Perspective of Toxicology Information Systems. -- Books and Special Documents: -- G.L. Kennedy, Jr., P. Wexler, N.S. Selzer, and L.A. Malley. -- General Texts. -- Analytical Toxicology. -- Animals in Research. -- Biomonitoring/Biomarkers. -- Biotechnology. -- Biotoxins. -- Cancer. -- Chemical Compendia. -- Chemical--Cosmetics and Other Consumer. -- Products. -- Chemical--Drugs. -- Chemical--Dust and Fibers. -- Chemical--Metals. -- Chemicals--Pesticides -- Chemicals--Solvents. -- Chemical--Selected Chemicals. -- Clinical Toxicology. -- Developmental and Reproductive Toxicology. -- Environmental Toxicology--General. -- Environmental Toxicology-- Aquatic. -- Environmental Toxicology--Atmospheric. -- Environmental Toxicology--Hazardous Waste. -- Environmental Toxicology--Terrestrial. -- Environmental Toxicology--Wildlife. -- Ep ...

Author: Bruce Anderson
Publisher: Elsevier
ISBN: 0080548008
Category : Medical
Languages : en
Pages : 9894

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Book Description
The second edition of the Encyclopedia of Toxicology continues its comprehensive survey of toxicology. This new edition continues to present entries devoted to key concepts and specific chemicals. There has been an increase in entries devoted to international organizations and well-known toxic-related incidents such as Love Canal and Chernobyl. Along with the traditional scientifically based entries, new articles focus on the societal implications of toxicological knowledge including environmental crimes, chemical and biological warfare in ancient times, and a history of the U.S. environmental movement. With more than 1150 entries, this second edition has been expanded in length, breadth and depth, and provides an extensive overview of the many facets of toxicology. Also available online via ScienceDirect – featuring extensive browsing, searching, and internal cross-referencing between articles in the work, plus dynamic linking to journal articles and abstract databases, making navigation flexible and easy. For more information, pricing options and availability visit www.info.sciencedirect.com. *Second edition has been expanded to 4 volumes *Encyclopedic A-Z arrangement of chemicals and all core areas of the science of toxicology *Covers related areas such as organizations, toxic accidents, historical and social issues, and laws *New topics covered include computational toxicology, cancer potency factors, chemical accidents, non-lethal chemical weapons, drugs of abuse, and consumer products and many more!

Author: Shayne C. Gad
Publisher: Academic Press
ISBN: 9780080525921
Category : Medical
Languages : en
Pages : 534

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Book Description
Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health. Key Features * Over 100 tables summarizing and interpreting results * Complete coverage of all major test designs and their limitations and advantages * Current status of alternative test designs and models