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Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 1040163769
Category : Medical
Languages : en
Pages : 528
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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 da
Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 1040163769
Category : Medical
Languages : en
Pages : 528
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 da
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: Elsevier
ISBN: 0323984622
Category : Medical
Languages : en
Pages : 1074
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Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes 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 expectations associated with working in nonclinical toxicology
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: Elsa Nielsen
Publisher: CRC Press
ISBN: 1420006940
Category : Medical
Languages : en
Pages : 450
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Book Description
Unlike many existing books on toxicology that cover either toxicity of a particular substance or toxicity of chemicals on particular organ systems, Toxicological Risk Assessment of Chemicals: A Practical Guide lays out the principle activities of conducting a toxicological risk assessment, including international approaches and methods for the risk
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: 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: 1040194990
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, includin
Author: W. Waynon Johnson
Publisher:
ISBN:
Category : Acute toxicity testing
Languages : en
Pages : 106
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Book Description
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.
