Global Approach In Safety Testing

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Global Approach in Safety Testing

Author : Jan Willem van der Laan
Publisher : Springer Science & Business Media
ISBN 13 : 1461459508
Total Pages : 322 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Global Approach in Safety Testing by : Jan Willem van der Laan

Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

Engineering a Safer World

Author : Nancy G. Leveson
Publisher : MIT Press
ISBN 13 : 0262297302
Total Pages : 555 pages
Book Rating : 4.2/5 (622 download)

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Book Synopsis Engineering a Safer World by : Nancy G. Leveson

Download or read book Engineering a Safer World written by Nancy G. Leveson and published by MIT Press. This book was released on 2012-01-13 with total page 555 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new approach to safety, based on systems thinking, that is more effective, less costly, and easier to use than current techniques. Engineering has experienced a technological revolution, but the basic engineering techniques applied in safety and reliability engineering, created in a simpler, analog world, have changed very little over the years. In this groundbreaking book, Nancy Leveson proposes a new approach to safety—more suited to today's complex, sociotechnical, software-intensive world—based on modern systems thinking and systems theory. Revisiting and updating ideas pioneered by 1950s aerospace engineers in their System Safety concept, and testing her new model extensively on real-world examples, Leveson has created a new approach to safety that is more effective, less expensive, and easier to use than current techniques. Arguing that traditional models of causality are inadequate, Leveson presents a new, extended model of causation (Systems-Theoretic Accident Model and Processes, or STAMP), then shows how the new model can be used to create techniques for system safety engineering, including accident analysis, hazard analysis, system design, safety in operations, and management of safety-critical systems. She applies the new techniques to real-world events including the friendly-fire loss of a U.S. Blackhawk helicopter in the first Gulf War; the Vioxx recall; the U.S. Navy SUBSAFE program; and the bacterial contamination of a public water supply in a Canadian town. Leveson's approach is relevant even beyond safety engineering, offering techniques for “reengineering” any large sociotechnical system to improve safety and manage risk.

Science, Medicine, and Animals

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309101174
Total Pages : 23 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Science, Medicine, and Animals by : National Research Council

Download or read book Science, Medicine, and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Toxicokinetics

Author :
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Toxicokinetics by :

Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Assessing Microbial Safety of Drinking Water Improving Approaches and Methods

Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264099476
Total Pages : 292 pages
Book Rating : 4.2/5 (64 download)

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Book Synopsis Assessing Microbial Safety of Drinking Water Improving Approaches and Methods by : OECD

Download or read book Assessing Microbial Safety of Drinking Water Improving Approaches and Methods written by OECD and published by OECD Publishing. This book was released on 2003-03-20 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a state-of-the-art review on approaches and methods used in assessing the microbial safety of drinking-water.

Validation of Alternative Methods for Toxicity Testing

Author : Chantra Eskes
Publisher : Springer
ISBN 13 : 3319338269
Total Pages : 407 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Validation of Alternative Methods for Toxicity Testing by : Chantra Eskes

Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Author : Joerg Bluemel
Publisher : Academic Press
ISBN 13 : 012417146X
Total Pages : 716 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by : Joerg Bluemel

Download or read book The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment written by Joerg Bluemel and published by Academic Press. This book was released on 2015-03-13 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

The Interplay of Global Standards and EU Pharmaceutical Regulation

Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
ISBN 13 : 1509943013
Total Pages : 288 pages
Book Rating : 4.5/5 (99 download)

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Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz

Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Proceedings of the 5th International Probabilistic Workshop

Author : Luc Taerwe
Publisher : Dirk Proske Verlag
ISBN 13 : 3000220305
Total Pages : 396 pages
Book Rating : 4.0/5 (2 download)

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Book Synopsis Proceedings of the 5th International Probabilistic Workshop by : Luc Taerwe

Download or read book Proceedings of the 5th International Probabilistic Workshop written by Luc Taerwe and published by Dirk Proske Verlag. This book was released on 2007 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Keeping Patients Safe

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309187362
Total Pages : 485 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Keeping Patients Safe by : Institute of Medicine

Download or read book Keeping Patients Safe written by Institute of Medicine and published by National Academies Press. This book was released on 2004-03-27 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building on the revolutionary Institute of Medicine reports To Err is Human and Crossing the Quality Chasm, Keeping Patients Safe lays out guidelines for improving patient safety by changing nurses' working conditions and demands. Licensed nurses and unlicensed nursing assistants are critical participants in our national effort to protect patients from health care errors. The nature of the activities nurses typically perform â€" monitoring patients, educating home caretakers, performing treatments, and rescuing patients who are in crisis â€" provides an indispensable resource in detecting and remedying error-producing defects in the U.S. health care system. During the past two decades, substantial changes have been made in the organization and delivery of health care â€" and consequently in the job description and work environment of nurses. As patients are increasingly cared for as outpatients, nurses in hospitals and nursing homes deal with greater severity of illness. Problems in management practices, employee deployment, work and workspace design, and the basic safety culture of health care organizations place patients at further risk. This newest edition in the groundbreaking Institute of Medicine Quality Chasm series discusses the key aspects of the work environment for nurses and reviews the potential improvements in working conditions that are likely to have an impact on patient safety.

Finite Element Analysis for Building Assessment

Author : Paulo B. Lourenço
Publisher : Taylor & Francis
ISBN 13 : 100056312X
Total Pages : 423 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Finite Element Analysis for Building Assessment by : Paulo B. Lourenço

Download or read book Finite Element Analysis for Building Assessment written by Paulo B. Lourenço and published by Taylor & Francis. This book was released on 2022-05-23 with total page 423 pages. Available in PDF, EPUB and Kindle. Book excerpt: Existing structures represent a heterogeneous category in the global built environment as often characterized by the presence of archaic materials, damage and disconnections, uncommon construction techniques and subsequent interventions throughout the building history. In this scenario, the common linear elastic analysis approach adopted for new buildings is incapable of an accurate estimation of structural capacity, leading to overconservative results, invasive structural strengthening, added intervention costs, excessive interference to building users and possible losses in terms of aesthetics or heritage values. For a rational and sustainable use of the resources, this book deals with advanced numerical simulations, adopting a practical approach to introduce the fundamentals of Finite Element Method, nonlinear solution procedures and constitutive material models. Recommended material properties for masonry, timber, reinforced concrete, iron and steel are discussed according to experimental evidence, building standards and codes of practice. The examples examined throughout the book and in the conclusive chapter support the analyst’s decision-making process toward a safe and efficient use of finite element analysis. Written primarily for practicing engineers, the book is of value to students in engineering and technical architecture with solid knowledge in the field of continuum mechanics and structural design.

Pharmacokinetics

Author :
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Pharmacokinetics by :

Download or read book Pharmacokinetics written by and published by . This book was released on 1995 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:

System Safety Engineering and Risk Assessment

Author : Nicholas J. Bahr
Publisher : CRC Press
ISBN 13 : 1466551615
Total Pages : 444 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis System Safety Engineering and Risk Assessment by : Nicholas J. Bahr

Download or read book System Safety Engineering and Risk Assessment written by Nicholas J. Bahr and published by CRC Press. This book was released on 2018-10-08 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system

Aquatic Toxicology and Hazard Assessment

Author :
Publisher : ASTM International
ISBN 13 :
Total Pages : 475 pages
Book Rating : 4./5 ( download)

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Book Synopsis Aquatic Toxicology and Hazard Assessment by :

Download or read book Aquatic Toxicology and Hazard Assessment written by and published by ASTM International. This book was released on 1982 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Aquatic Toxicology and Hazard Assessment

Author : D. R. Branson
Publisher : ASTM International
ISBN 13 : 9780803107991
Total Pages : 494 pages
Book Rating : 4.1/5 (79 download)

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Book Synopsis Aquatic Toxicology and Hazard Assessment by : D. R. Branson

Download or read book Aquatic Toxicology and Hazard Assessment written by D. R. Branson and published by ASTM International. This book was released on 1981-09 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ensuring Global Food Safety

Author : Christine Boisrobert
Publisher : Academic Press
ISBN 13 : 0080889301
Total Pages : 475 pages
Book Rating : 4.0/5 (88 download)

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Book Synopsis Ensuring Global Food Safety by : Christine Boisrobert

Download or read book Ensuring Global Food Safety written by Christine Boisrobert and published by Academic Press. This book was released on 2009-11-11 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation. Reduce amount of food destroyed due to difference in regulations between nations Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all" Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions Employ proven science to obtain global consensus for regulations Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions

Improving Food Safety Through a One Health Approach

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309259363
Total Pages : 418 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving Food Safety Through a One Health Approach by : Institute of Medicine

Download or read book Improving Food Safety Through a One Health Approach written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-10 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization of the food supply has created conditions favorable for the emergence, reemergence, and spread of food-borne pathogens-compounding the challenge of anticipating, detecting, and effectively responding to food-borne threats to health. In the United States, food-borne agents affect 1 out of 6 individuals and cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year. This figure likely represents just the tip of the iceberg, because it fails to account for the broad array of food-borne illnesses or for their wide-ranging repercussions for consumers, government, and the food industry-both domestically and internationally. A One Health approach to food safety may hold the promise of harnessing and integrating the expertise and resources from across the spectrum of multiple health domains including the human and veterinary medical and plant pathology communities with those of the wildlife and aquatic health and ecology communities. The IOM's Forum on Microbial Threats hosted a public workshop on December 13 and 14, 2011 that examined issues critical to the protection of the nation's food supply. The workshop explored existing knowledge and unanswered questions on the nature and extent of food-borne threats to health. Participants discussed the globalization of the U.S. food supply and the burden of illness associated with foodborne threats to health; considered the spectrum of food-borne threats as well as illustrative case studies; reviewed existing research, policies, and practices to prevent and mitigate foodborne threats; and, identified opportunities to reduce future threats to the nation's food supply through the use of a "One Health" approach to food safety. Improving Food Safety Through a One Health Approach: Workshop Summary covers the events of the workshop and explains the recommendations for future related workshops.