Safety 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.

Safety Data, Analysis, and Evaluation 2011

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (772 download)

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Book Synopsis Safety Data, Analysis, and Evaluation 2011 by :

Download or read book Safety Data, Analysis, and Evaluation 2011 written by and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safety Data, Analysis, and Evaluation

Author :
Publisher :
ISBN 13 : 9780309099622
Total Pages : 210 pages
Book Rating : 4.0/5 (996 download)

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Book Synopsis Safety Data, Analysis, and Evaluation by :

Download or read book Safety Data, Analysis, and Evaluation written by and published by . This book was released on 2006 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safety Data, Analysis, and Evaluation 2018

Author :
Publisher :
ISBN 13 : 9781510882461
Total Pages : pages
Book Rating : 4.8/5 (824 download)

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Book Synopsis Safety Data, Analysis, and Evaluation 2018 by :

Download or read book Safety Data, Analysis, and Evaluation 2018 written by and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Product Safety Evaluation

Author : Jie Chen
Publisher : CRC Press
ISBN 13 : 1351021966
Total Pages : 220 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 220 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.

Safety Data, Analysis, and Evaluation 2009

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (567 download)

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Book Synopsis Safety Data, Analysis, and Evaluation 2009 by :

Download or read book Safety Data, Analysis, and Evaluation 2009 written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Traffic Flow Theory and Characteristics

Author :
Publisher :
ISBN 13 : 9780309441407
Total Pages : 97 pages
Book Rating : 4.4/5 (414 download)

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Book Synopsis Traffic Flow Theory and Characteristics by :

Download or read book Traffic Flow Theory and Characteristics written by and published by . This book was released on 2016 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safety Data, Analysis, and Evaluation 2011

Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (965 download)

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Book Synopsis Safety Data, Analysis, and Evaluation 2011 by :

Download or read book Safety Data, Analysis, and Evaluation 2011 written by and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Drug Safety Data

Author : Michael J. Klepper
Publisher : Jones & Bartlett Learning
ISBN 13 : 0763769126
Total Pages : 332 pages
Book Rating : 4.7/5 (637 download)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2011 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 provides pharmaceutical scientists, researchers 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 premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, 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 provides 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 tipsàand 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)

Quantitative Evaluation of Safety in Drug Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1466555459
Total Pages : 386 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang

Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Statistical Methods and Safety Data Analysis and Evaluation

Author : National Research Council (U.S.). Transportation Research Board
Publisher :
ISBN 13 :
Total Pages : 224 pages
Book Rating : 4.X/5 (4 download)

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Book Synopsis Statistical Methods and Safety Data Analysis and Evaluation by : National Research Council (U.S.). Transportation Research Board

Download or read book Statistical Methods and Safety Data Analysis and Evaluation written by National Research Council (U.S.). Transportation Research Board and published by . This book was released on 2004 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Statistical Methods and Modeling and Safety Data, Analysis, and Evaluation

Author : National Research Council (U.S.). Transportation Research Board
Publisher :
ISBN 13 :
Total Pages : 212 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Statistical Methods and Modeling and Safety Data, Analysis, and Evaluation by : National Research Council (U.S.). Transportation Research Board

Download or read book Statistical Methods and Modeling and Safety Data, Analysis, and Evaluation written by National Research Council (U.S.). Transportation Research Board and published by . This book was released on 2003 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers empirical approaches to outlier detection in intelligent transportation systems data, modeling of traffic crash-flow relationships for intersections, profiling of high-frequency accident locations by use of association rules, analysis of rollovers and injuries with sport utility vehicles, and automated accident detection at intersections via digital audio signal processing.

Highway Safety Data, Analysis, and Evaluation, 2010

Author :
Publisher :
ISBN 13 :
Total Pages : 122 pages
Book Rating : 4.:/5 (696 download)

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Book Synopsis Highway Safety Data, Analysis, and Evaluation, 2010 by :

Download or read book Highway Safety Data, Analysis, and Evaluation, 2010 written by and published by . This book was released on 2010 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Statistical Methods

Author : National Research Council (U.S.). Transportation Research Board
Publisher :
ISBN 13 :
Total Pages : 254 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Statistical Methods by : National Research Council (U.S.). Transportation Research Board

Download or read book Statistical Methods written by National Research Council (U.S.). Transportation Research Board and published by . This book was released on 2005 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Transportation Research Record contains 28 papers dealing with statistical methods in highway safety research; highway safety data, analysis, and evaluation; occupant protection; and systematic reviews and meta-analysis. The papers address such topics as risk and crash prediction models, crashes on freeways and at signalized intersections, multivehicle crash prediction, speed and safety, red light running crashes, freeway lane closures, ramp design, accident exposure, rumble strip benefits, collisions with median trees, intersection safety, accident reconstruction, safety effects of speed limit changes, geometric design and head-on crashes, deer-vehicle crashes, sport utility vehicle rollover, vehicle occupancy and crash risk, a logit model for studying injury severity, abdominal injuries in rail passengers, healthy transport policies, and meta-analysis.

Statistical Methods, Highway Safety Data, Analysis and Evaluation, Occupant Protection, Systematic Reviews and Meta-analysis

Author :
Publisher :
ISBN 13 :
Total Pages : 235 pages
Book Rating : 4.:/5 (156 download)

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Book Synopsis Statistical Methods, Highway Safety Data, Analysis and Evaluation, Occupant Protection, Systematic Reviews and Meta-analysis by :

Download or read book Statistical Methods, Highway Safety Data, Analysis and Evaluation, Occupant Protection, Systematic Reviews and Meta-analysis written by and published by . This book was released on 2005 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Reliability Assessment of Safety and Production Systems

Author : Jean-Pierre Signoret
Publisher : Springer Nature
ISBN 13 : 3030647080
Total Pages : 878 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis Reliability Assessment of Safety and Production Systems by : Jean-Pierre Signoret

Download or read book Reliability Assessment of Safety and Production Systems written by Jean-Pierre Signoret and published by Springer Nature. This book was released on 2021-03-23 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides, as simply as possible, sound foundations for an in-depth understanding of reliability engineering with regard to qualitative analysis, modelling, and probabilistic calculations of safety and production systems. Drawing on the authors’ extensive experience within the field of reliability engineering, it addresses and discusses a variety of topics, including: • Background and overview of safety and dependability studies; • Explanation and critical analysis of definitions related to core concepts; • Risk identification through qualitative approaches (preliminary hazard analysis, HAZOP, FMECA, etc.); • Modelling of industrial systems through static (fault tree, reliability block diagram), sequential (cause-consequence diagrams, event trees, LOPA, bowtie), and dynamic (Markov graphs, Petri nets) approaches; • Probabilistic calculations through state-of-the-art analytical or Monte Carlo simulation techniques; • Analysis, modelling, and calculations of common cause failure and uncertainties; • Linkages and combinations between the various modelling and calculation approaches; • Reliability data collection and standardization. The book features illustrations, explanations, examples, and exercises to help readers gain a detailed understanding of the topic and implement it into their own work. Further, it analyses the production availability of production systems and the functional safety of safety systems (SIL calculations), showcasing specific applications of the general theory discussed. Given its scope, this book is a valuable resource for engineers, software designers, standard developers, professors, and students.

Statistical Methods, Safety Data, Analysis, and Evaluation, 2007

Author :
Publisher :
ISBN 13 :
Total Pages : 264 pages
Book Rating : 4.:/5 (276 download)

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Book Synopsis Statistical Methods, Safety Data, Analysis, and Evaluation, 2007 by :

Download or read book Statistical Methods, Safety Data, Analysis, and Evaluation, 2007 written by and published by . This book was released on 2007 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Includes 30 papers that explore modeling crash frequency by severity, time series analysis of road risk, crash data analysis using bootstrapped maximum likelihood method, time series analysis of the effect of holidays on daily traffic counts, regression-to-mean effect in traffic safety evaluation, roundabouts, and the safety impact of improved signal visibility."--TRB summary website.