Download or read book Drug Safety Data How to Analyze Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Download or read book Wiley Guide to Chemical Incompatibilities written by Richard P. Pohanish and published by John Wiley & Sons. This book was released on 2005-03-11 with total page 1296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Second Edition of the Wiley Guide to Chemical Incompatibilities provides chemists, technicians, and engineers with a thorough, lightening-quick resource to use during experimental preparation and in the event of an emergency. Includes: Hard-to-find data on over 11,000 chemical compounds 2,000 more chemical listings than the First Edition Alphabetical organization providing concise incompatibility profiles for thousands of commonly used commercial chemcials CAS Numbers to eliminate confusion among similar synonym names. A glossary of general chemical terms This expanded Second Edition, set out in a convenient, easy-to-use format, is an essential guide for all safety, first-response, and plant management professionals working with chemical materials.

Download or read book Data Centric Safety written by Alastair Faulkner and published by Elsevier. This book was released on 2020-05-27 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data-Centric Safety presents core concepts and principles of system safety management, and then guides the reader through the application of these techniques and measures to Data-Centric Systems (DCS). The authors have compiled their decades of experience in industry and academia to provide guidance on the management of safety risk. Data Safety has become increasingly important as many solutions depend on data for their correct and safe operation and assurance. The book's content covers the definition and use of data. It recognises that data is frequently used as the basis of operational decisions and that DCS are often used to reduce user oversight. This data is often invisible, hidden. DCS analysis is based on a Data Safety Model (DSM). The DSM provides the basis for a toolkit leading to improvement recommendations. It also discusses operation and oversight of DCS and the organisations that use them. The content covers incident management, providing an outline for incident response. Incident investigation is explored to address evidence collection and management.Current standards do not adequately address how to manage data (and the errors it may contain) and this leads to incidents, possibly loss of life. The DSM toolset is based on Interface Agreements to create soft boundaries to help engineers facilitate proportionate analysis, rationalisation and management of data safety. Data-Centric Safety is ideal for engineers who are working in the field of data safety management.This book will help developers and safety engineers to: - Determine what data can be used in safety systems, and what it can be used for - Verify that the data being used is appropriate and has the right characteristics, illustrated through a set of application areas - Engineer their systems to ensure they are robust to data errors and failures

Download or read book Handbook of Chemical Compound Data for Process Safety written by Carl L. Yaws and published by Elsevier. This book was released on 1997-03-25 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides comprehensive safety and health-related data for hydrocarbons and organic chemicals as well as selected data for inorganic chemicals.

Download or read book Highway Safety Analytics and Modeling written by Dominique Lord and published by Elsevier. This book was released on 2021-02-27 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highway Safety Analytics and Modeling comprehensively covers the key elements needed to make effective transportation engineering and policy decisions based on highway safety data analysis in a single. reference. The book includes all aspects of the decision-making process, from collecting and assembling data to developing models and evaluating analysis results. It discusses the challenges of working with crash and naturalistic data, identifies problems and proposes well-researched methods to solve them. Finally, the book examines the nuances associated with safety data analysis and shows how to best use the information to develop countermeasures, policies, and programs to reduce the frequency and severity of traffic crashes. - Complements the Highway Safety Manual by the American Association of State Highway and Transportation Officials - Provides examples and case studies for most models and methods - Includes learning aids such as online data, examples and solutions to problems

Download or read book Health Safety and Environmental Data Analysis written by Anthony J. Joseph and published by CRC Press. This book was released on 2020-07-09 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in environmental health and safety (EHS) management use statistics every day in making decisions. This book was created to provide the quantitative tools and techniques necessary to make important EHS assessments. Readers need not be statistically or mathematically inclined to make the most of this book-mathematical derivations are kept to a minimum and subjects are approached in a simple and factual manner, complemented with plenty of real-world examples. Chapters 1-3 cover knowledge of basic statistical concepts such as presentation of data, measurements of location and dispersion, and elementary probability and distributions. Data gathering and analysis topics including sampling methods, sampling theory, testing, and interference as well as skills for critically evaluating published numerical material is presented in Chapters 4-6. Chapters 7-11 discuss information generation topics-regression and correlation analysis, time series, linear programming, network and Gnatt charting, and decision analysis-tools that can be used to convert data into meaningful information. Chapter 12 features six examples of projects made successful through statistical approaches being applied. Readers can use these approaches to solve their own unique problems. Whether you are a EHS professional, manager, or student, Health, Safety, and Environmental Data Analysis: A Business Approach will help you communicate statistical data effectively.

Download or read book Emergency Response Guidebook written by U.S. Department of Transportation and published by Simon and Schuster. This book was released on 2013-06-03 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Does the identification number 60 indicate a toxic substance or a flammable solid, in the molten state at an elevated temperature? Does the identification number 1035 indicate ethane or butane? What is the difference between natural gas transmission pipelines and natural gas distribution pipelines? If you came upon an overturned truck on the highway that was leaking, would you be able to identify if it was hazardous and know what steps to take? Questions like these and more are answered in the Emergency Response Guidebook. Learn how to identify symbols for and vehicles carrying toxic, flammable, explosive, radioactive, or otherwise harmful substances and how to respond once an incident involving those substances has been identified. Always be prepared in situations that are unfamiliar and dangerous and know how to rectify them. Keeping this guide around at all times will ensure that, if you were to come upon a transportation situation involving hazardous substances or dangerous goods, you will be able to help keep others and yourself out of danger. With color-coded pages for quick and easy reference, this is the official manual used by first responders in the United States and Canada for transportation incidents involving dangerous goods or hazardous materials.

Download or read book Highway Safety Improved Monitoring and Oversight of Traffic Safety Data Program are Needed Report to Congressional Committees written by and published by . This book was released on 2004 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report examines the quality of state crash information; the activities states undertook using 411 grant funds to improve their traffic safety data systems, and the progress they made using the grant funds; and NHTSA's oversight of the grant program

Download or read book Prudent Practices in the Laboratory written by National Research Council and published by National Academies Press. This book was released on 2011-03-25 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prudent Practices in the Laboratory-the book that has served for decades as the standard for chemical laboratory safety practice-now features updates and new topics. This revised edition has an expanded chapter on chemical management and delves into new areas, such as nanotechnology, laboratory security, and emergency planning. Developed by experts from academia and industry, with specialties in such areas as chemical sciences, pollution prevention, and laboratory safety, Prudent Practices in the Laboratory provides guidance on planning procedures for the handling, storage, and disposal of chemicals. The book offers prudent practices designed to promote safety and includes practical information on assessing hazards, managing chemicals, disposing of wastes, and more. Prudent Practices in the Laboratory will continue to serve as the leading source of chemical safety guidelines for people working with laboratory chemicals: research chemists, technicians, safety officers, educators, and students.

Download or read book Code of Federal Regulations written by and published by . This book was released on 1996 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Sax s Dangerous Properties of Industrial Materials 3 Volume Set written by Richard J. Lewis (Sr.) and published by Wiley-Interscience. This book was released on 2000 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its inception in the early 1950s, this work has become the "bible" for those who need to evaluate the hazard of substances used in commerce. It is the only reference that combines, for so many substances, data on toxicological, fire, reactivity, explosive potential, and regulatory information. Highly acclaimed in the professional journals, it was reviewed as "an indispensable reference guide for professionals responsible for managing industrial safety and occupational exposure...an extraordinary work," and as "a monumental work...Efforts like this are the things of what history is made," among other reviews.

Download or read book Niosh Pocket Guide to Chemical Hazards written by Niosh and published by www.Militarybookshop.CompanyUK. This book was released on 2012-06-01 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: The NIOSH Pocket Guide to Chemical Hazards presents information taken from the NIOSH/OSHA Occupational Health Guidelines for Chemical Hazards, from National Institute for Occupational Safety and Health (NIOSH) criteria documents and Current Intelligence Bulletins, and from recognized references in the fields of industrial hygiene, occupational medicine, toxicology, and analytical chemistry. The information is presented in tabular form to provide a quick, convenient source of information on general industrial hygiene practices. The information in the Pocket Guide includes chemical structures or formulas, identification codes, synonyms, exposure limits, chemical and physical properties, incompatibilities and reactivities, measurement methods, respirator selections, signs and symptoms of exposure, and procedures for emergency treatment.

Download or read book Laboratory Safety Guide written by and published by . This book was released on 2004 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Data and Safety Monitoring Committees in Clinical Trials written by Jay Herson and published by CRC Press. This book was released on 2016-12-19 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

Download or read book State Traffic Safety Information written by and published by . This book was released on 1997 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Safe Management of Wastes from Health care Activities written by Yves Chartier and published by World Health Organization. This book was released on 2014 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.