Predictive Toxicology In Drug Safety

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Predictive Toxicology in Drug Safety

Author : Jinghai J. Xu
Publisher : Cambridge University Press
ISBN 13 : 1139493094
Total Pages : pages
Book Rating : 4.1/5 (394 download)

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Book Synopsis Predictive Toxicology in Drug Safety by : Jinghai J. Xu

Download or read book Predictive Toxicology in Drug Safety written by Jinghai J. Xu and published by Cambridge University Press. This book was released on 2010-09-27 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment and promotes evidence-based toxicology. Each specific area of toxicology relevant for drug discovery is discussed in detail, including theory, experimental approaches and data interpretation supported by comprehensive up-to-date references. Many chapters provide fascinating case studies, which are of general interest for those who have basic science training and are interested in how chemicals interact with the human body.

Predictive Toxicology

Author : Friedlieb Pfannkuch
Publisher : John Wiley & Sons
ISBN 13 : 3527336087
Total Pages : 430 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Predictive Toxicology by : Friedlieb Pfannkuch

Download or read book Predictive Toxicology written by Friedlieb Pfannkuch and published by John Wiley & Sons. This book was released on 2015-01-20 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ein moderner integrierter Ansatz für die Sicherheitsprüfung in der Arzneimittelentwicklung: Dieses Praktikerbuch behandelt In-silico- und In-vitro-Methoden sowie den Einsatz von Biomarkern, mit denen bei kleinen Arzneistoffmolekülen und Biologika frühzeitig und zuverlässig Toxizitäts-Screenings durchgeführt werden können.

Drug Discovery Toxicology

Author : Yvonne Will
Publisher : John Wiley & Sons
ISBN 13 : 1119053331
Total Pages : 598 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Discovery Toxicology by : Yvonne Will

Download or read book Drug Discovery Toxicology written by Yvonne Will and published by John Wiley & Sons. This book was released on 2016-04-18 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309112982
Total Pages : 300 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment by : National Research Council

Download or read book Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2007-12-19 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new waysâ€"an effort requiring funding, interagency coordination, and data management strategies.

New Horizons in Predictive Toxicology

Author : Alan G. E. Wilson
Publisher : Royal Society of Chemistry
ISBN 13 : 1849730512
Total Pages : 711 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis New Horizons in Predictive Toxicology by : Alan G. E. Wilson

Download or read book New Horizons in Predictive Toxicology written by Alan G. E. Wilson and published by Royal Society of Chemistry. This book was released on 2012 with total page 711 pages. Available in PDF, EPUB and Kindle. Book excerpt: The sophistication of modelling and simulation technologies have improved dramatically over the past decade and their applications in toxicity prediction and risk assessment are of critical importance. The integration of predictive toxicology approaches will become increasingly necessary as industrial chemicals advance and as new pharmaceuticals enter the market. In this comprehensive discussion of predictive toxicology and its applications, leading experts express their views on the technologies currently available and the potential for future developments. The book covers a wide range of topics including in silico, in vitro and in vivo approaches that are being used in the safety assessment of chemical substances. It reflects the growing and urgent need to strengthen and improve our ability to predict the safety and risks posed by industrial and pharmaceutical chemicals in humans. The reader will find extensive information on the use of current animal models used for various toxicities and target mediated toxicities. Also discussed are the recent regulatory initiatives to improve the safety assessment of chemicals. The book provides an expert and comprehensive discussion on the current status and future directions of predictive toxicology and its application. The various chapters in the book also reflect the growing need for improvements in our technologies and abilities to predict toxicities of pharmaceutical and industrial chemicals to ensure product safety and protect public health.

The Future of Predictive Safety Evaluation

Author : D.V. Parke
Publisher : Springer Science & Business Media
ISBN 13 : 9400941390
Total Pages : 226 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis The Future of Predictive Safety Evaluation by : D.V. Parke

Download or read book The Future of Predictive Safety Evaluation written by D.V. Parke and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: A. N. WORDEN, D. V. PARKE AND J. MARKS THE BACKGROUND There is nothing new about the fact that chemical substances derived either from natural products or by synthetic means .. can give rise to toxicity in animals and human beings, and that they must be subjected to controls. The earliest writings speak of such toxicity and, from the times of ancient Egypt and in the Old Tes tament, controls have existed[l]. In the Middle Ages Paracelsus (1493-1541) noted that "All things are poisons, for there is nothing without poisonous qualities. It is only the dose which makes a thing a poison", and hence he stressed the importance of dose relative to toxic reactions [ 2] . Most of the early controls concentrated on substances that were to be deliberately administered to the human subject in the form of medicines. Legislation for many centuries was mainly con cerned with regulating the activities of apothecaries and physicians. The Royal College of Physicians, for example, was originally established to control the activities of physicians within London. Among the controls which it exerted was that over the use of medicinal substances. Such controls were, however, poor, based as they were on hearsay evidence of toxicity. For many centuries no means existed for the accurate determination of toxicity.

Emerging Safety Science

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309110122
Total Pages : 150 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Emerging Safety Science by : Institute of Medicine

Download or read book Emerging Safety Science written by Institute of Medicine and published by National Academies Press. This book was released on 2008-05-08 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.

Drug Safety Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 1119755859
Total Pages : 996 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2023-01-12 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Author : Ali S. Faqi
Publisher : Academic Press
ISBN 13 : 0128036214
Total Pages : 988 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi

Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2016-11-03 with total page 988 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author : Ali S. Faqi
Publisher : Academic Press
ISBN 13 : 0123878152
Total Pages : 904 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi

Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-11-02 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --

Predictive Analytics for Toxicology

Author : Luis G. Valerio, Jr.
Publisher : CRC Press
ISBN 13 : 1040101836
Total Pages : 253 pages
Book Rating : 4.0/5 (41 download)

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Book Synopsis Predictive Analytics for Toxicology by : Luis G. Valerio, Jr.

Download or read book Predictive Analytics for Toxicology written by Luis G. Valerio, Jr. and published by CRC Press. This book was released on 2024-08-13 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Predictive data science is already in use in many fields, but its application in toxicology is new and sought after by non-animal alternative testing initiatives. Predictive Analytics for Toxicology: Applications in Discovery Science provides a comprehensive overview of the application of predictive analytics in the field of toxicology, highlighting its role and applications in discovery science. This book addresses the challenges of accurately predicting high-level endpoints of toxicity and explores the use of computational and artificial intelligence research to automate predictive toxicology. It underscores the importance of predictive toxicology in proposing and explaining adverse outcomes resulting from human exposures to specific toxicants, especially when experimental and observational data on the toxicant are incomplete or unavailable. Key features: Includes a plain language description of predictive analytics in toxicology adding an overview of the wide range of applications Examines the science of prediction, computational models as an automated science and comprehensive discussions on concepts of machine learning Opens the hood on AI and its applications in toxicology Features coverage on how in silico toxicity predictions are translational science tools The book integrates strategies and practices of predictive toxicology and offers practical information that students and professionals of the toxicology, chemical, and pharmaceutical industries will find essential. It fulfills the expectations of student researchers seeking to learn predictive analytics in toxicology. This book will energize scientists to conduct predictive toxicology modeling using artificial intelligence and machine learning, and inspire students and seasoned scientists interested in automated science to pick up new research using predictive in silico models to evaluate chemical-induced toxicity. With its focus on practical applications and real-world examples, this book serves as a guide for navigating the complex issues and practices of discovery toxicology. It is an essential resource for those interested in computer-based methods in toxicology, providing valuable insights into the use of predictive analytics.

The Future of Predictive Safety Evaluation

Author : A.N. Worden
Publisher : Springer Science & Business Media
ISBN 13 : 9400932014
Total Pages : 309 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis The Future of Predictive Safety Evaluation by : A.N. Worden

Download or read book The Future of Predictive Safety Evaluation written by A.N. Worden and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 477 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Drug Safety Evaluation

Author : Jean-Charles Gautier
Publisher : Humana Press
ISBN 13 : 9781607618508
Total Pages : 431 pages
Book Rating : 4.6/5 (185 download)

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Book Synopsis Drug Safety Evaluation by : Jean-Charles Gautier

Download or read book Drug Safety Evaluation written by Jean-Charles Gautier and published by Humana Press. This book was released on 2011-08-24 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular BiologyTM series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.

Histopathology of Preclinical Toxicity Studies

Author : Peter Greaves
Publisher : Academic Press
ISBN 13 : 0444538615
Total Pages : 893 pages
Book Rating : 4.4/5 (445 download)

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Book Synopsis Histopathology of Preclinical Toxicity Studies by : Peter Greaves

Download or read book Histopathology of Preclinical Toxicity Studies written by Peter Greaves and published by Academic Press. This book was released on 2011-10-07 with total page 893 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new 4th edition of Histopathology of Preclinical Toxicity Studies is now completely in full color and continues to describe the pathology found in drug safety studies in laboratory animals with an evidence-based discussion of the relevance of these findings to the clinical investigation of new drugs for humans. Organized according to organ systems, this revision features a thoroughly updated bibliography and discusses new drug-induced pathologies and applicable species comparisons to aid in the preclinical safety assessment of new medicines. This updated reference is essential for those involved in drug safety evaluation, including pathologists, toxicologists and pharmacologists working in corporate, government, academic and research settings. This edition is in full color and features nearly 200 high-quality images Provides extended commentary on the relevance of pathological findings and features a fully updated bibliography containing sources for further reading Includes new content coverage on the commonly used transgenic animal models that are used in safety assessment, specific tumor types induced by drugs in rodents, and new drug-induced pathologies and lesions

Predictive Toxicology

Author : Christoph Helma
Publisher : CRC Press
ISBN 13 : 0849350352
Total Pages : 522 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Predictive Toxicology by : Christoph Helma

Download or read book Predictive Toxicology written by Christoph Helma and published by CRC Press. This book was released on 2005-03-17 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive overview of techniques and systems currently utilized in predictive toxicology, this reference presents an in-depth survey of strategies, algorithms, and prediction methods to select, calculate, and represent the features and properties of chemical structures in biological systems. It provides sources of high-quality toxicity data, the most important commercial and noncommercial predictive toxicology programs, and advanced technologies in computational chemistry, biology, statistics, and data mining. Predictive Toxicology explores applications that go beyond classical structure-activity relationships and discusses programs such as OncoLogic, META, MC4PC, PASS, and lazar.

Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition

Author :
Publisher : ScholarlyEditions
ISBN 13 : 1464967091
Total Pages : 365 pages
Book Rating : 4.4/5 (649 download)

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Book Synopsis Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition by :

Download or read book Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition written by and published by ScholarlyEditions. This book was released on 2012-01-09 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Drug Management, Toxicology, Monitoring, Resistance, and Safety. The editors have built Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Drug Management, Toxicology, Monitoring, Resistance, and Safety in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.