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Author : Nordisk Ministerråd
Publisher : Nordic Council of Ministers
ISBN 13 : 9289311967
Total Pages : 54 pages
Book Rating : 4.2/5 (893 download)
Download or read book Threshold of Toxicological Concern (TTC) written by Nordisk Ministerråd and published by Nordic Council of Ministers. This book was released on 2005-08-11 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 0470934751
Total Pages : 455 pages
Book Rating : 4.4/5 (79 download)
Download or read book Genotoxic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2011-03-29 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Author :
Publisher :
ISBN 13 : 9789289336369
Total Pages : 53 pages
Book Rating : 4.3/5 (363 download)
Download or read book Threshold of Toxicological Concern (TTC) written by and published by . This book was released on 2005 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abstract: In the regulation of food contact articles and flavouring substances, the TTC concept (Threshold of Toxicological Concern) has been developed as a substitute for substance-specific information. The TTC concept is based on the analysis of the toxicological and/or structural data of a broad range of different chemicals, with the aim to set an exposure-value below which no toxicity testing is necessary. Recently, application of the TTC concept has been proposed as a tool in risk assessment of industrial chemicals within REACH, both for defining when no testing is needed based on exposure information and as a substitute for effect values. The proposal concerns both human health and the environment. The present report does not advocate the use of TTC instead of substance specific toxicity data for risk assessment of industrial chemicals within REACH at time being. This conclusion is based on current knowledge and understanding of the concept, and on limitations and uncertainties in the derivation of TTCs. Furthermore, the suitability of the TTC concept so far has not been evaluated for the diverse group of industrial chemicals. In addition, the possible consequences for the level of protection of human health and the environment resulting from applying the TTC concept in the risk assessment should be examined
Author : Susan Barlow
Publisher : International Life Science Inst
ISBN 13 : 9781578811885
Total Pages : 32 pages
Book Rating : 4.8/5 (118 download)
Download or read book Threshold of Toxicological Concern (TTC) written by Susan Barlow and published by International Life Science Inst. This book was released on 2005 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Alexandra Maertens
Publisher : Royal Society of Chemistry
ISBN 13 : 1839164409
Total Pages : 307 pages
Book Rating : 4.8/5 (391 download)
Download or read book Green Toxicology written by Alexandra Maertens and published by Royal Society of Chemistry. This book was released on 2022-02-01 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: Green toxicology is an integral part of green chemistry. One of the key goals of green chemistry is to design less toxic chemicals. Therefore, an understanding of toxicology and hazard assessment is important for any chemist working in green chemistry, but toxicology is rarely part of most chemists' education. As a consequence, chemists lack the toxicological lens necessary to view chemicals in order to design safer substitutions. This book seeks to fill that gap and demonstrate how a basic understanding of toxicology, as well as the tools of in silico and in vitro toxicology, can be an integral part of green chemistry. R&D chemists, product stewards, and toxicologists who work in the field of sustainability, can all benefit from integrating green toxicology principles into their work. Topics include in silico tools for hazard assessment, toxicity testing, and lifecycle considerations, this book aims to act as a bridge between green toxicologists and green chemists.
Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1119551218
Total Pages : 548 pages
Book Rating : 4.1/5 (195 download)
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309224624
Total Pages : 276 pages
Book Rating : 4.3/5 (92 download)
Download or read book Water Reuse written by National Research Council and published by National Academies Press. This book was released on 2012-07-17 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Expanding water reuse-the use of treated wastewater for beneficial purposes including irrigation, industrial uses, and drinking water augmentation-could significantly increase the nation's total available water resources. Water Reuse presents a portfolio of treatment options available to mitigate water quality issues in reclaimed water along with new analysis suggesting that the risk of exposure to certain microbial and chemical contaminants from drinking reclaimed water does not appear to be any higher than the risk experienced in at least some current drinking water treatment systems, and may be orders of magnitude lower. This report recommends adjustments to the federal regulatory framework that could enhance public health protection for both planned and unplanned (or de facto) reuse and increase public confidence in water reuse.
Author : Helmut Greim
Publisher : John Wiley & Sons
ISBN 13 : 1119135923
Total Pages : 840 pages
Book Rating : 4.1/5 (191 download)
Download or read book Toxicology and Risk Assessment written by Helmut Greim and published by John Wiley & Sons. This book was released on 2018-08-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.
Author : Cheeseman
Publisher :
ISBN 13 : 9781118288689
Total Pages : 400 pages
Book Rating : 4.2/5 (886 download)
Download or read book The Threshold of Toxicological Concern written by Cheeseman and published by . This book was released on 2014-06-10 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The threshold of toxicological concern (TTC) is becoming of increasing interest as a tool for industry and regulators to characterize the risk of human exposure to chemicals. Including contributions from industry experts, regulators, and academics, The Threshold of Toxicological Concern discusses the history / principles of the TTC and its application for risk and safety assessments in the key industries: food, pharmaceuticals, and cosmetics. The book is designed to help risk assessors to prioritize risk analysis efforts by applying TTC criteria with low-levels of chemical exposure.
Author : Cornelis A. M. van Gestel
Publisher : CRC Press
ISBN 13 : 1439830096
Total Pages : 312 pages
Book Rating : 4.4/5 (398 download)
Download or read book Mixture Toxicity written by Cornelis A. M. van Gestel and published by CRC Press. This book was released on 2016-04-19 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the last decade and a half, great progress has been made in the development of concepts and models for mixture toxicity, both in human and environmental toxicology. However, due to their different protection goals, developments have often progressed in parallel but with little integration. Arguably the first book to clearly link ecotoxicology an
Author :
Publisher :
ISBN 13 :
Total Pages : 94 pages
Book Rating : 4.3/5 (91 download)
Download or read book EPA 630/R written by and published by . This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Franz-Xaver Reichl
Publisher : Springer
ISBN 13 : 9783642353734
Total Pages : 0 pages
Book Rating : 4.3/5 (537 download)
Download or read book Regulatory Toxicology written by Franz-Xaver Reichl and published by Springer. This book was released on 2014-03-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Mark T. D. Cronin
Publisher : Royal Society of Chemistry
ISBN 13 : 1849730040
Total Pages : 689 pages
Book Rating : 4.8/5 (497 download)
Download or read book In Silico Toxicology written by Mark T. D. Cronin and published by Royal Society of Chemistry. This book was released on 2010 with total page 689 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book defines the use of computational approaches to predict the environmental toxicity and human health effects of organic chemicals.
Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971116
Total Pages : 740 pages
Book Rating : 4.1/5 (189 download)
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author : Thomas Engel
Publisher : John Wiley & Sons
ISBN 13 : 352734201X
Total Pages : 660 pages
Book Rating : 4.5/5 (273 download)
Download or read book Applied Chemoinformatics written by Thomas Engel and published by John Wiley & Sons. This book was released on 2018-06-05 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edited by world-famous pioneers in chemoinformatics, this is a clearly structured and applications-oriented approach to the topic, providing up-to-date and focused information on the wide range of applications in this exciting field. The authors explain methods and software tools, such that the reader will not only learn the basics but also how to use the different software packages available. Experts describe applications in such different fields as structure-spectra correlations, virtual screening, prediction of active sites, library design, the prediction of the properties of chemicals, the development of new cosmetics products, quality control in food, the design of new materials with improved properties, toxicity modeling, assessment of the risk of chemicals, and the control of chemical processes. The book is aimed at advanced students as well as lectures but also at scientists that want to learn how chemoinformatics could assist them in solving their daily scientific tasks. Together with the corresponding textbook Chemoinformatics - Basic Concepts and Methods (ISBN 9783527331093) on the fundamentals of chemoinformatics readers will have a comprehensive overview of the field.
Author : Nava Dayan
Publisher : John Wiley & Sons
ISBN 13 : 1118056795
Total Pages : 445 pages
Book Rating : 4.1/5 (18 download)
Download or read book Formulating, Packaging, and Marketing of Natural Cosmetic Products written by Nava Dayan and published by John Wiley & Sons. This book was released on 2011-06-15 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: Balanced coverage of natural cosmetics, and what it really means to be "green" The use of natural ingredients and functional botanical compounds in cosmetic products is on the rise. According to industry estimates, sales of natural personal care products have exceeded $7 billion in recent years. Nonetheless, many misconceptions about natural products for instance, what "green" and "organic" really mean continue to exist within the industry. Formulating, Packaging, and Marketing of Natural Cosmetic Products addresses this confusion head-on, exploring and detailing the sources, processing, safety, efficacy, stability, and formulation aspects of natural compounds in cosmetic and personal care products. Designed to provide industry professionals and natural product development experts with the essential perspective and market information needed to develop truly "green" cosmetics, the book covers timely issues like biodegradable packaging and the potential microbial risks they present, the use of Nuclear Magnetic Resonance (NMR) to identify biomarkers, and chromatographic methods of analyzing natural products. A must-read for industry insiders, Formulating, Packaging, and Marketing of Natural Cosmetic Products provides the reader with basic tools and concepts to develop naturally derived formulas.
Author : Douglas J. Ball
Publisher : John Wiley & Sons
ISBN 13 : 0470173653
Total Pages : 702 pages
Book Rating : 4.4/5 (71 download)
Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
