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Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 9780849338588
Category : Medical
Languages : en
Pages : 499
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Book Description
Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements. Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials.
Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 9780849338588
Category : Medical
Languages : en
Pages : 499
Get Book Here
Book Description
Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements. Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials.
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878160
Category : Medical
Languages : en
Pages : 903
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Book Description
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
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: W. Waynon Johnson
Publisher:
ISBN:
Category : Acute toxicity testing
Languages : en
Pages : 106
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Book Description
Author: David J. Hoffman
Publisher: CRC Press
ISBN: 142003250X
Category : Science
Languages : en
Pages : 1316
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Book Description
Completely revised and updated with 18 new chapters, this second edition includes contributions from over 75 international experts. Also, a Technical Review Board reviewed all manuscripts for accuracy and currency. Focusing on toxic substance and how they affect the ecosystems worldwide, the book presents methods for quantifying and measuring ecotoxicological effects in the field and in the lab, as well as methods for estimating, predicting, and modeling in ecotoxicology studies. This is the definitive reference for students, researchers, consultants, and other professionals in the environmental sciences, toxicology, chemistry, biology, and ecology - in academia, industry, and government.
Author: Jacobson-Kram David
Publisher: CRC Press
ISBN: 9780824700737
Category : Medical
Languages : en
Pages : 442
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Book Description
Designed to aid toxicology testing study design, this text provides data on issues such as species selection, dose level and dosing regimes, animal models, routes of exposure, statistical evaluation, data interpretation, fulfillment of regulatory requirements, and adherence to good laboratory practices.
Author: Lars Friberg
Publisher: Elsevier Science & Technology
ISBN:
Category : Medical
Languages : en
Pages : 758
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Book Description
Chapters on specific metals include physical and chemical properties, methods and problems of analysis, production and uses, environmental levels and exposures, metabolism, levels in tissues and biological fluids, effects and dose-response relationships, carcinogenicity, mutagenicity, teratogenicity and preventative measures, diagnosis, treatment and prognosis.
Author: Swaran Jeet Singh Flora
Publisher: Academic Press
ISBN: 0124199550
Category : Science
Languages : en
Pages : 752
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Book Description
Throughout history, arsenic has been used as an effective and lethal poison. Today, arsenic continues to present a real threat to human health all over the world, as it contaminates groundwater and food supplies. Handbook of Arsenic Toxicology presents the latest findings on arsenic, its chemistry, its sources and its acute and chronic effects on the environment and human health. The book takes readings systematically through the target organs, before detailing current preventative and counter measures. This reference enables readers to effectively assess the risks related to arsenic, and provide a comprehensive look at arsenic exposure, toxicity and toxicity prevention. - Brings together current findings on the effects of arsenic on the environment and human health - Includes state-of-the-art techniques in arsenic toxicokinetics, speciation and molecular mechanisms - Provides all the information needed for effective risk assessment, prevention and countermeasure
Author: Michael J. Derelanko
Publisher: CRC Press
ISBN: 1351857177
Category : Medical
Languages : en
Pages : 533
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Book Description
The third edition of the Toxicologist’s Pocket Handbook, like the first two editions, is a scaled-down version of the best-selling Handbook of Toxicology. It provides the most frequently used toxicology reference information in a convenient pocket-sized book. The format remains the same as the earlier editions to allow basic reference information to be located quickly, with the information placed in sections specific to subspecialties of toxicology. A detailed table of contents lists all tables and figures contained in the book by section. This expanded edition contains a number of tables not found in the second edition added to sections on lab animals, general toxicology, dermal and ocular toxicology, genetic toxicology/carcinogenesis, neurotoxicology, immunotoxicology, reproductive/developmental toxicology, industrial chemical, and pharmaceutical toxicology. New information is presented for additional laboratory animals such as swine and primates, infusion recommendations, newer methods such as the local lymph node assay, and reference safety pharmacology values for standard species. Additional information on typical genetic toxicology and immunotoxicology assays as well as in vitro assays for eye irritation are provided. Some tables from the second edition have been updated to include new information that has arisen since the earlier edition went to press. Information from the second edition, such as regulatory requirements that are no longer applicable, has been deleted.
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.
