Qsar In Safety Evaluation And Risk Assessment

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• Author : Huixiao Hong
• Publisher : Academic Press
• Release Date : 2023-09-01
• Total pages : 0
• ISBN : 0443153396
• File Size : 16,7 Mb
• Total Download : 857
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Download QSAR in Safety Evaluation and Risk Assessment in PDF, Epub, and Kindle

QSAR in Safety Evaluation and Risk Assessment provides comprehensive coverage on QSAR methods, tools, data sources, and models focusing on applications in products safety evaluation and chemicals risk assessment. Organized into five parts, the book covers almost allmost aspects of QSAR modeling and application. Topics in the book include methods of QSAR, from both scientific and regulatory viewpoints; data sources available for facilitating QSAR models development; software tools for QSAR development; and QSAR models developed for assisting safety evaluation and risk assessment. Chapter contributors are authored by a lineup of active scientists in this field. The chapters not only provide professional level technical summarizations but also cover introductory descriptions for all aspects of QSAR for safety evaluation and risk assessment.

• Author : C.J. van Leeuwen,J.L.M. Hermens
• Publisher : Springer Science & Business Media
• Release Date : 2012-12-06
• Total pages : 374
• ISBN : 9789401585200
• File Size : 34,5 Mb
• Total Download : 713
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Download Risk Assessment of Chemicals: An Introduction in PDF, Epub, and Kindle

In recent years many developments have taken place in promote co-operation between governments and other the field of risk assessment of chemicals. Many reports parties involved in chemical safety and to provide policy have been published by national authorities, industries guidance with emphasis on regional and subregional co and scientific researchers as well as by international bod operation. The Inter-Organization Programme for the ies such as the European Union, the Organization of Sound Management of Chemicals (IOMC) was estab Economic Cooperation and Development (OECD) and lished in 1995 and provides a mechanism for the six par the joint International Programme on Chemical Safety ticipating organizations (UNEP, ILO, FAO, UNIDO,WHO (IPCS) of the World Health Organization (WHO), the and OECD) to better co-ordinate policies and activities in International Labour Organization (lLO), and the United the field of chemical risk management. Nations Environment Programme (UNEP). The present book is an introduction to risk assessment of The development and international harmonization of risk chemicals. It contains basic background information on assessment methods is an important challenge. In sources, emissions, distribution and fate processes for Agenda 21 of the United Nations Conference on exposure estimation. It includes dose-effects estimation Environment and Development (UNCED), chapter 19 is for both human health related toxicology and ecotoxicol entirely devoted to the management of chemicals. For ogy as well as information on estimation methodologies. one of its recommendations, i. e.

• Author : Shayne C. Gad
• Publisher : Springer Nature
• Release Date : 2020-02-24
• Total pages : 490
• ISBN : 9783030352417
• File Size : 54,9 Mb
• Total Download : 817
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Download Integrated Safety and Risk Assessment for Medical Devices and Combination Products in PDF, Epub, and Kindle

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

• Author : Sean Ekins
• Publisher : John Wiley & Sons
• Release Date : 2018-02-13
• Total pages : 450
• ISBN : 9781119282563
• File Size : 32,5 Mb
• Total Download : 368
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Download Computational Toxicology in PDF, Epub, and Kindle

A key resource for toxicologists across a broad spectrum of fields, this book offers a comprehensive analysis of molecular modelling approaches and strategies applied to risk assessment for pharmaceutical and environmental chemicals. Provides a perspective of what is currently achievable with computational toxicology and a view to future developments Helps readers overcome questions of data sources, curation, treatment, and how to model / interpret critical endpoints that support 21st century hazard assessment Assembles cutting-edge concepts and leading authors into a unique and powerful single-source reference Includes in-depth looks at QSAR models, physicochemical drug properties, structure-based drug targeting, chemical mixture assessments, and environmental modeling Features coverage about consumer product safety assessment and chemical defense along with chapters on open source toxicology and big data

• Author : Shayne Cox Gad
• Publisher : John Wiley & Sons
• Release Date : 2016-11-18
• Total pages : 918
• ISBN : 9781119097402
• File Size : 50,5 Mb
• Total Download : 885
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Download Drug Safety Evaluation in PDF, Epub, and Kindle

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

• Author : Shayne Cox Gad,Dexter W. Sullivan, Jr.
• Publisher : John Wiley & Sons
• Release Date : 2023-01-05
• Total pages : 996
• ISBN : 9781119755876
• File Size : 55,7 Mb
• Total Download : 256
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Download Drug Safety Evaluation in PDF, Epub, and Kindle

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

• Author : Kunal Roy,Supratik Kar,Rudra Narayan Das
• Publisher : Academic Press
• Release Date : 2015-03-03
• Total pages : 484
• ISBN : 9780128016336
• File Size : 21,7 Mb
• Total Download : 793
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Download Understanding the Basics of QSAR for Applications in Pharmaceutical Sciences and Risk Assessment in PDF, Epub, and Kindle

Understanding the Basics of QSAR for Applications in Pharmaceutical Sciences and Risk Assessment describes the historical evolution of quantitative structure-activity relationship (QSAR) approaches and their fundamental principles. This book includes clear, introductory coverage of the statistical methods applied in QSAR and new QSAR techniques, such as HQSAR and G-QSAR. Containing real-world examples that illustrate important methodologies, this book identifies QSAR as a valuable tool for many different applications, including drug discovery, predictive toxicology and risk assessment. Written in a straightforward and engaging manner, this is the ideal resource for all those looking for general and practical knowledge of QSAR methods. Includes numerous practical examples related to QSAR methods and applications Follows the Organization for Economic Co-operation and Development principles for QSAR model development Discusses related techniques such as structure-based design and the combination of structure- and ligand-based design tools

• Author : Cornelis A. M. van Gestel,Martijs Jonker,Jan E. Kammenga,Ryszard Laskowski,Claus Svendsen
• Publisher : CRC Press
• Release Date : 2016-04-19
• Total pages : 320
• ISBN : 1439830096
• File Size : 23,5 Mb
• Total Download : 869
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Download Mixture Toxicity in PDF, Epub, and Kindle

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 and classic human toxicology, Mixture Toxicity: Linking Approaches from Ecological and Human Toxicology incorporates extensive reviews of exposure to toxicants, toxicokinetics and toxicodynamics, toxicity of mixtures, and risk assessment. The book examines developments in both fields, compares and contrasts their current state of the art, and identifies where one field can learn from the other. Each chapter provides an essential overview of the state of the art in both human and ecotoxicological mixture risk assessment, focusing on the work published in the last fifteen years. The coverage progresses from exposure to risk assessment, at each step identifying the special complications typically raised by mixtures. Based on in-depth discussions among specialists representing different disciplines and approaches, the chapters each address: Exposure — how to quantify the amounts of chemicals that may enter the living organism Kinetics, dynamics, and metabolism — how the chemicals enter an organism, travel within the organism, how they are metabolized and reach the target site, and explain development of toxicity with time Toxicity — what are the chemicals’ detrimental effects on the organism Test design and complex mixture characterization — how chemicals interact, how to measure effects of mixtures, and how to identify responsible chemicals Risk assessment — how to assess for risks in humans and the environment An unusual combination of different points of view on exposure to and risk assessment of chemical mixtures, this book summarizes current knowledge on combined effects of toxicant mixtures, information that is generally only available in a very fragmented form as individual journal papers. It identifies possible crosslinks and includes recommendations for mutual developments that can improve the state of knowledge on mixture toxicity and ultimately lead to better and more integrated risk assessment.

• Author : Federation of European Chemical Societies
• Publisher : Unknown
• Release Date : 1988
• Total pages : 614
• ISBN : UOM:49015001139626
• File Size : 49,8 Mb
• Total Download : 984
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Download Risk Assessment of Chemicals in the Environment in PDF, Epub, and Kindle

Reviews the current status of risk assessment procedures as they relate to the environment.

• Author : Peter P. Calow
• Publisher : John Wiley & Sons
• Release Date : 2009-07-08
• Total pages : 600
• ISBN : 9781444313192
• File Size : 30,9 Mb
• Total Download : 430
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Download Handbook of Environmental Risk Assessment and Management in PDF, Epub, and Kindle

At the heart of environmental protection is risk assessment: thelikelihood of pollution from accidents; the likelihood of problemsfrom normal and abnormal operation of industrial processes; thelikely impacts associated with new synthetic chemicals; and so on.Currently, risk assessment has been very much in the news--therisks from BSE and E. coli, and the public perception of risks fromnuclear waste, etc. This new publication explains how scientificmethodologies are used to assess risk from human activities and theresultant objects and wastes, on people and the environment.Understanding such risks supplies crucial information--to framelegislation, manage major habitats, businesses and industries, andcreate development programmes. Unique in combining the science of risk assessment with thedevelopment of management strategies. Covers science and social science (politics, economics,psychology) aspects. Very timely - risk assessment lies at the heart of decisionmaking in various topical environmental questions (BSE, Brent Spar,nuclear waste).

• Author : Mark T. D. Cronin,Judith C. Madden
• Publisher : Royal Society of Chemistry
• Release Date : 2010
• Total pages : 689
• ISBN : 9781849730044
• File Size : 36,8 Mb
• Total Download : 688
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Download In Silico Toxicology in PDF, Epub, and Kindle

In silico methods to predict toxicity are becoming increasingly important, particularly in light of European legislation such as Reach and the Cosmetics Regulation. They are also being used extensively worldwide e.g. in the USA, Canada, Japan and Australia. The objective of In Silico Toxicology: Principles and Applications is to enable the reader to develop new, and use existing, in silico methods to predict the toxicity and fate of chemicals. It develops the theme in a logical sequence leading the use through the retrieval, and assessment of quality, of toxicological data and information; the calculation of descriptors and properties; the basis of statistical techniques for quantitative structure-activity relationships (QSARS); the interpretation and validation of models for regulatory use; the mechanistic basis to modelling; as well as chemical grouping approaches and application of the models for risk assessment. The book also addresses other aspects of in silico toxicology including how to predict both external and internal exposure and the role of in silico approaches in integrated testing strategies. The contributions from recognised leaders in each of these areas include evidence of the use and applicability of approaches using real world case studies concerning both environmental and human health effects. The book is relevant to toxicologists and modellers using in silico toxicological approaches to perform risk assessment for regulatory purposes and product development. Series Editors: D Anderson, University of Bradford, Uk MD Waters, ILS, N Carolina, USA TC Marrs, Edentox Associates, Kent, UK The field of toxicological research is continually expanding and diversifying driven by the need to understand the human and ecological risks of exposure to chemicals and other toxicants. This series is devoted to coverage of modern toxicology and assessment of risk and is responding to the resurgence in interest in the of scientific investigation.

• Author : B.John Garrick,Willard C. Gekler
• Publisher : Springer Science & Business Media
• Release Date : 2013-11-11
• Total pages : 714
• ISBN : 9781489923707
• File Size : 14,7 Mb
• Total Download : 371
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Download The Analysis, Communication, and Perception of Risk in PDF, Epub, and Kindle

The 1989 Annual Meeting of the Society for Risk Analysis dramatically demonstrated one of the most important reasons for having the Society - to bring together people with highly diverse backgrounds and disciplines to assess the common problems of societal and individual risks. The physical scientists emphasized the analytical tools for assessing environmental effects and for modeling risks from engineered systems and other human activities. The health scientists presented numerous methods of analyzing health effects, including the subject of dose-response relationships, especially at low exposure levels - never an easy analysis. The social and political scientists concentrated on issues of risk perception, communication, acceptability, and human touch. Others discussed such issues as cost-benefit analysis and the risk-based approach to decision analysis. Use of risk assessment methods for risk management continued to be a matter of strong opinion and debate. The impacts of state and federal regulations, existing and planned, were assessed in sessions and in luncheon speeches. These impacts show that risk analysis practitioners will have an increasingly important role in the future. They will be challenged to provide clear, easily understood evaluations of risk that are responsive to society's concern for risk, as evidenced in laws and regulations. Of course, the various risk analysis specialties overlapped in domains of interest.

• Author : OECD
• Publisher : OECD Publishing
• Release Date : 2017-04-13
• Total pages : 23
• ISBN : 9789264274822
• File Size : 18,5 Mb
• Total Download : 404
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Download OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment in PDF, Epub, and Kindle

With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of ...

• Author : Kunal Roy
• Publisher : Springer
• Release Date : 2017-05-22
• Total pages : 555
• ISBN : 9783319568508
• File Size : 43,6 Mb
• Total Download : 766
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Download Advances in QSAR Modeling in PDF, Epub, and Kindle

The book covers theoretical background and methodology as well as all current applications of Quantitative Structure-Activity Relationships (QSAR). Written by an international group of recognized researchers, this edited volume discusses applications of QSAR in multiple disciplines such as chemistry, pharmacy, environmental and agricultural sciences addressing data gaps and modern regulatory requirements. Additionally, the applications of QSAR in food science and nanoscience have been included – two areas which have only recently been able to exploit this versatile tool. This timely addition to the series is aimed at graduate students, academics and industrial scientists interested in the latest advances and applications of QSAR.

• Author : P.J. Bert Hakkinen,Asish Mohapatra,Steven G. G. Gilbert
• Publisher : Academic Press
• Release Date : 2009-08-19
• Total pages : 1552
• ISBN : 0080920039
• File Size : 21,8 Mb
• Total Download : 372
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Download Information Resources in Toxicology in PDF, Epub, and Kindle

This latest version of Information Resources in Toxicology (IRT) continues a tradition established in 1982 with the publication of the first edition in presenting an extensive itemization, review, and commentary on the information infrastructure of the field. This book is a unique wide-ranging, international, annotated bibliography and compendium of major resources in toxicology and allied fields such as environmental and occupational health, chemical safety, and risk assessment. Thoroughly updated, the current edition analyzes technological changes and is rife with online tools and links to Web sites. IRT-IV is highly structured, providing easy access to its information. Among the “hot topics covered are Disaster Preparedness and Management, Nanotechnology, Omics, the Precautionary Principle, Risk Assessment, and Biological, Chemical and Radioactive Terrorism and Warfare are among the designated. • International in scope, with contributions from over 30 countries • Numerous key references and relevant Web links • Concise narratives about toxicologic sub-disciplines • Valuable appendices such as the IUPAC Glossary of Terms in Toxicology • Authored by experts in their respective sub-disciplines within toxicology

• Author : D.M. Pugh,J.V. Tarazona
• Publisher : Springer Science & Business Media
• Release Date : 2013-04-17
• Total pages : 269
• ISBN : 9789401153164
• File Size : 38,5 Mb
• Total Download : 833
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Download Regulation for Chemical Safety in Europe: Analysis, Comment and Criticism in PDF, Epub, and Kindle

Many European Union Directives seek to minimize the potential for harm to humans and the environment arising from the use of chemicals. This book takes an interdisciplinary, selective look at the effector mechanisms employed in such directives. It covers the pre-marketing use of toxicology to identify the hazardous properties of chemicals, acknowledging its shortcomings, while contrasting the scientific method with the precautionary principle in developing risk-management practices. The book then goes on to describe the use of bio-indicators, chemical analyses and mathematical modelling for prediction, or to determine the adequacy of chemical safety legislation. The environmental risk assessment of priority chemicals is described and the impact of pesticides on sustainability in agriculture is discussed from the differing standpoints of agronomy and economics. Audience: All professionals concerned with the safe management of chemicals and their use, including teachers, practitioners, policy makers or legislators.

• Author : Darrell R. Boverhof,B. Bhaskar Gollapudi
• Publisher : John Wiley & Sons
• Release Date : 2011-10-11
• Total pages : 392
• ISBN : 1118008987
• File Size : 36,7 Mb
• Total Download : 825
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Download Applications of Toxicogenomics in Safety Evaluation and Risk Assessment in PDF, Epub, and Kindle

This book provides a timely overview of toxicogenomics, with special emphasis on the practical applications of this technology to the risk assessment process. Introductory sections are followed by a series of chapters highlighting practical and systematic applications of toxicogenomics in informing the risk assessment process – including the areas of mutagenicity, carcinogenicity, endocrine toxicity, organ-specific toxicity, population monitoring, and ecotoxicology. The book concludes with approaches for the integration of this technology in safety evaluation studies, and an outlook on how toxicogenomics and complementary technologies can reframe the current risk assessment paradigm.

• Author : Andrew P. Worth,Mojca Fuart Gatnik,Elena Lo Piparo,Silvia Lapenna,Aleksandra Mostrag-Szlichtyng,Rositsa Serafimova
• Publisher : Unknown
• Release Date : 2011
• Total pages : 131
• ISBN : 9279195670
• File Size : 35,5 Mb
• Total Download : 278
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Download The Use of Computational Methods in the Toxicological Assessment of Chemicals in Food in PDF, Epub, and Kindle

A wide range of chemicals are intentionally added to, or unintentionally found in, food products, often in very small amounts. Depending on the situation, the experimental data needed to complete a dietary risk assessment, which is the scientific basis for protecting human health, may not be available or obtainable, for reasons of cost, time and animal welfare. For example, toxicity data are often lacking for the metabolites and degradation products of pesticide active ingredients. There is therefore an interest in the development and application of efficient and effective non-animal methods for assessing chemical toxicity, including Quantitative Structure-Activity Relationship (QSAR) models and related computational methods. This report gives an overview of how computational methods are currently used in the field of food safety by national regulatory bodies, international advisory organisations and the food industry. On the basis of an international survey, a comprehensive literature review and a detailed QSAR analysis, a range of recommendations are made with the long-term aim of promoting the judicious use of suitable QSAR methods. The current status of QSAR methods is reviewed not only for toxicological endpoints relevant to dietary risk assessment, but also for Absorption, Distribution, Metabolism and Excretion (ADME) properties, which are often important in discriminating between the toxicological profiles of parent compounds and their reaction products. By referring to the concept of the Threshold of Toxicological Concern (TTC), the risk assessment context in which QSAR methods can be expected to be used is also discussed. This report provides a summary and update of the findings obtained in a study carried out by the JRC under the terms of a contract awarded by the European Food Safety Authority (EFSA).

• Author : Thomas Engel,Johann Gasteiger
• Publisher : John Wiley & Sons
• Release Date : 2018-06-05
• Total pages : 646
• ISBN : 9783527342013
• File Size : 14,9 Mb
• Total Download : 616
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Download Applied Chemoinformatics in PDF, Epub, and Kindle

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 : Ramesh C. Gupta
• Publisher : Academic Press
• Release Date : 2015-01-21
• Total pages : 1198
• ISBN : 9780128004944
• File Size : 17,9 Mb
• Total Download : 976
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Download Handbook of Toxicology of Chemical Warfare Agents in PDF, Epub, and Kindle

Handbook of Toxicology of Chemical Warfare Agents, Second Edition covers every aspect of deadly toxic chemicals used in conflicts, warfare and terrorism. Including findings from experimental as well as clinical studies, this essential reference offers in-depth coverage of individual toxicants, target organ toxicity, major incidents, toxic effects in humans, animals and wildlife, biosensors and biomarkers, on-site and laboratory analytical methods, decontamination and detoxification procedures, and countermeasures. Expanding on the ground-breaking first edition, Handbook of Toxicology of Chemical Warfare Agents has been completely updated, presenting the most recent advances in field. Brand new chapters include a case study of the Iran-Iraq war, an overview of chemical weapons of mass destruction, explosives, ricin, the human respiratory system, alternative testing methods, brain injuries, and more. Unites world-leading experts to present cutting-edge, agent-specific information on chemical warfare agents and their adverse effects on human and animal health and the environment. Covers all aspects of chemical warfare agent modes of action, detection, prevention, therapeutic treatment and countermeasures. Features a full update on the first edition to reflect the most recent advances in the field as well as nine new chapters.

• Author : A.N. Worden,D.V. Parke,J. Marks
• Publisher : Springer Science & Business Media
• Release Date : 2012-12-06
• Total pages : 320
• ISBN : 9789400932012
• File Size : 52,6 Mb
• Total Download : 954
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Download The Future of Predictive Safety Evaluation in PDF, Epub, and Kindle

Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.