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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Author : Michael J. Klepper

Publisher : Jones & Bartlett Publishers

Page : 332 pages

File Size : 22,29 MB

Release : 2010-09-15

Category : Medical

ISBN : 1449671551

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Book Description

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)



Wiley Guide to Chemical Incompatibilities

Author : Richard P. Pohanish

Publisher : John Wiley & Sons

Page : 1296 pages

File Size : 20,89 MB

Release : 2005-03-11

Category : Technology & Engineering

ISBN : 047172162X

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Book Description

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.



Data-Centric Safety

Author : Alastair Faulkner

Publisher : Elsevier

Page : 542 pages

File Size : 31,11 MB

Release : 2020-05-27

Category : Technology & Engineering

ISBN : 0128233222

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Book Description

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



Handbook of Chemical Compound Data for Process Safety

Author : Carl L. Yaws

Publisher : Elsevier

Page : 233 pages

File Size : 36,20 MB

Release : 1997-03-25

Category : Technology & Engineering

ISBN : 0080533396

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Book Description

This book provides comprehensive safety and health-related data for hydrocarbons and organic chemicals as well as selected data for inorganic chemicals.



Highway Safety Analytics and Modeling

Author : Dominique Lord

Publisher : Elsevier

Page : 504 pages

File Size : 49,82 MB

Release : 2021-02-27

Category : Law

ISBN : 0128168196

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Book Description

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



Health, Safety, and Environmental Data Analysis

Author : Anthony J. Joseph

Publisher : CRC Press

Page : 164 pages

File Size : 48,95 MB

Release : 2020-07-09

Category : Technology & Engineering

ISBN : 0429605455

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Book Description

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.



Emergency Response Guidebook

Author : U.S. Department of Transportation

Publisher : Simon and Schuster

Page : 352 pages

File Size : 18,24 MB

Release : 2013-06-03

Category : House & Home

ISBN : 1626363765

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Book Description

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.



Human Reliability and Safety Analysis Data Handbook

Author : David I. Gertman

Publisher : John Wiley & Sons

Page : 480 pages

File Size : 21,22 MB

Release : 1993-12-16

Category : Technology & Engineering

ISBN : 9780471591108

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Book Description

Takes into account the human element as well as the classical aspects of mechanical, electrical and chemical designs that contribute to risk. Features a significant amount of data essential for risk analysis not normally available. Contains numerous examples of authentic applications and case studies.



Highway Safety: Improved Monitoring and Oversight of Traffic Safety Data Program are Needed: Report to Congressional Committees

Author :

Publisher :

Page : 58 pages

File Size : 10,33 MB

Release : 2004

Category : Federal aid to transportation

ISBN :

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Book Description

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



Niosh Pocket Guide to Chemical Hazards

Author : Niosh

Publisher : www.Militarybookshop.CompanyUK

Page : 456 pages

File Size : 11,56 MB

Release : 2012-06-01

Category : Technology & Engineering

ISBN : 9781780398518

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Book Description

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.