Saftey Data Analysis And Evaluation

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Medical Product Safety Evaluation

Author : Jie Chen
Publisher : CRC Press
ISBN 13 : 1351021974
Total Pages : 372 pages
Book Rating : 4.3/5 (51 download)

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Book Synopsis Medical Product Safety Evaluation by : Jie Chen

Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

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

Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449671551
Total Pages : 332 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk by : Michael J. Klepper

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)

Highway Safety Analytics and Modeling

Author : Dominique Lord
Publisher : Elsevier
ISBN 13 : 0128168196
Total Pages : 504 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Highway Safety Analytics and Modeling by : Dominique Lord

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

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

ASP

Author :
Publisher :
ISBN 13 :
Total Pages : 232 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis ASP by :

Download or read book ASP written by and published by . This book was released on 1980 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmacovigilance: A Practical Approach

Author : Thao Doan
Publisher : Elsevier Health Sciences
ISBN 13 : 032358117X
Total Pages : 229 pages
Book Rating : 4.3/5 (235 download)

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Book Synopsis Pharmacovigilance: A Practical Approach by : Thao Doan

Download or read book Pharmacovigilance: A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. - Covers the evolving regulatory landscape, as well as current and future use of digital technologies. - Uses case studies to ensure content is relevant to everyday practice. - Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. - Consolidates today's available information on this timely topic into one convenient resource.

Annual Report

Author : U.S. Nuclear Regulatory Commission
Publisher :
ISBN 13 :
Total Pages : 450 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Annual Report by : U.S. Nuclear Regulatory Commission

Download or read book Annual Report written by U.S. Nuclear Regulatory Commission and published by . This book was released on with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safe Mobility

Author : Dominique Lord
Publisher : Emerald Group Publishing
ISBN 13 : 1786352230
Total Pages : 511 pages
Book Rating : 4.7/5 (863 download)

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Book Synopsis Safe Mobility by : Dominique Lord

Download or read book Safe Mobility written by Dominique Lord and published by Emerald Group Publishing. This book was released on 2018-04-18 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book increases the level of knowledge on road safety contexts, issues and challenges; shares what can currently be done to address the variety of issues; and points to what needs to be done to make further gains in road safety.

Patient Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309090776
Total Pages : 551 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Patient Safety by : Institute of Medicine

Download or read book Patient Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2003-12-20 with total page 551 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans should be able to count on receiving health care that is safe. To achieve this, a new health care delivery system is needed â€" a system that both prevents errors from occurring, and learns from them when they do occur. The development of such a system requires a commitment by all stakeholders to a culture of safety and to the development of improved information systems for the delivery of health care. This national health information infrastructure is needed to provide immediate access to complete patient information and decision-support tools for clinicians and their patients. In addition, this infrastructure must capture patient safety information as a by-product of care and use this information to design even safer delivery systems. Health data standards are both a critical and time-sensitive building block of the national health information infrastructure. Building on the Institute of Medicine reports To Err Is Human and Crossing the Quality Chasm, Patient Safety puts forward a road map for the development and adoption of key health care data standards to support both information exchange and the reporting and analysis of patient safety data.

Title List of Documents Made Publicly Available

Author :
Publisher :
ISBN 13 :
Total Pages : 1010 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Title List of Documents Made Publicly Available by :

Download or read book Title List of Documents Made Publicly Available written by and published by . This book was released on with total page 1010 pages. Available in PDF, EPUB and Kindle. Book excerpt:

ERDA.

Author :
Publisher :
ISBN 13 :
Total Pages : 120 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis ERDA. by :

Download or read book ERDA. written by and published by . This book was released on 1977 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Staff Studies, Nuclear Accident and Recovery at Three Mile Island

Author : United States. Congress. Senate. Committee on Environment and Public Works. Subcommittee on Nuclear Regulation
Publisher :
ISBN 13 :
Total Pages : 564 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Staff Studies, Nuclear Accident and Recovery at Three Mile Island by : United States. Congress. Senate. Committee on Environment and Public Works. Subcommittee on Nuclear Regulation

Download or read book Staff Studies, Nuclear Accident and Recovery at Three Mile Island written by United States. Congress. Senate. Committee on Environment and Public Works. Subcommittee on Nuclear Regulation and published by . This book was released on 1980 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook of International Large-Scale Assessment

Author : Leslie Rutkowski
Publisher : CRC Press
ISBN 13 : 1439895147
Total Pages : 623 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Handbook of International Large-Scale Assessment by : Leslie Rutkowski

Download or read book Handbook of International Large-Scale Assessment written by Leslie Rutkowski and published by CRC Press. This book was released on 2013-11-12 with total page 623 pages. Available in PDF, EPUB and Kindle. Book excerpt: Winner of the 2017 AERA Division D Significant Contribution to Educational Measurement and Research Methodology Award! Technological and statistical advances, along with a strong interest in gathering more information about the state of our educational systems, have made it possible to assess more students, in more countries, more often, and in more subject domains. The Handbook of International Large-Scale Assessment: Background, Technical Issues, and Methods of Data Analysis brings together recognized scholars in the field of ILSA, behavioral statistics, and policy to develop a detailed guide that goes beyond database user manuals. After highlighting the importance of ILSA data to policy and research, the book reviews methodological aspects and features of the studies based on operational considerations, analytics, and reporting. The book then describes methods of interest to advanced graduate students, researchers, and policy analysts who have a good grounding in quantitative methods, but who are not necessarily quantitative methodologists. In addition, it provides a detailed exposition of the technical details behind these assessments, including the test design, the sampling framework, and estimation methods, with a focus on how these issues impact analysis choices.

Best Estimate Safety Analysis for Nuclear Power Plants

Author :
Publisher :
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Best Estimate Safety Analysis for Nuclear Power Plants by :

Download or read book Best Estimate Safety Analysis for Nuclear Power Plants written by and published by . This book was released on 2008 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Deterministic safety analysis is an important tool for confirming the adequacy and efficiency of provisions within the defence in depth concept for the safety of nuclear power plants (NPPs). IAEA Safety Standards Series No. NS-R-1.2 and Safety Reports Series No. 23 recommend, as one of the options for demonstrating the inclusion of adequate safety margins, the use of best estimate computer codes with realistic input data in combination with the evaluation of uncertainties in the calculation results. The evaluation of uncertainties is an issue of considerable complexity, and this Safety Report has been developed to complement the existing publications. It provides more detailed information on the methods available for the evaluation of uncertainties in deterministic safety analysis of NPPs and practical guidance in the use of these methods.

Vigilance Unleashed

Author : Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra
Publisher : Notion Press
ISBN 13 :
Total Pages : 171 pages
Book Rating : 4.8/5 (96 download)

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Book Synopsis Vigilance Unleashed by : Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra

Download or read book Vigilance Unleashed written by Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra and published by Notion Press. This book was released on 2023-09-13 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the world of pharmacovigilance, where patient safety takes center stage. In "Vigilance Unleashed: From Adverse Events to Patient Protection," we delve into the science and practices that safeguard patients from medication and medical devices' risks. Unravel the historical background, regulatory frameworks, and international collaborations that shape pharmacovigilance practices. From identifying adverse drug reactions to embracing emerging technologies and patient-centered approaches, this comprehensive guide equips readers with essential knowledge to navigate the dynamic landscape of pharmacovigilance confidently. Join us on this journey to champion patient safety and unleash the power of vigilance in healthcare.

Hearings, Reports and Prints of the Senate Committee on Environment and Public Works

Author : United States. Congress. Senate. Committee on Environment and Public Works
Publisher :
ISBN 13 :
Total Pages : 578 pages
Book Rating : 4.:/5 (35 download)

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Book Synopsis Hearings, Reports and Prints of the Senate Committee on Environment and Public Works by : United States. Congress. Senate. Committee on Environment and Public Works

Download or read book Hearings, Reports and Prints of the Senate Committee on Environment and Public Works written by United States. Congress. Senate. Committee on Environment and Public Works and published by . This book was released on 1980 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Risk Management Handbook for Health Care Organizations, 3 Volume Set

Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470649194
Total Pages : 2125 pages
Book Rating : 4.4/5 (76 download)

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Book Synopsis Risk Management Handbook for Health Care Organizations, 3 Volume Set by :

Download or read book Risk Management Handbook for Health Care Organizations, 3 Volume Set written by and published by John Wiley & Sons. This book was released on 2011-01-06 with total page 2125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continuing its superiority in the health care risk management field, this sixth edition of The Risk Management Handbook for Health Care Organizations is written by the key practitioners and consultant in the field. It contains more practical chapters and health care examples and additional material on methods and techniques of risk reduction and management. It also revises the structure of the previous edition, and focuses on operational and organizational structure rather than risk areas and functions. The three volumes are written using a practical and user-friendly approach.