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Book Statistical Methods and Safety Data Analysis and Evaluation

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:

Book Medical Product Safety Evaluation

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.

Book Statistical Methods for Survival Data Analysis

Download or read book Statistical Methods for Survival Data Analysis written by Elisa T. Lee and published by John Wiley & Sons. This book was released on 2013-09-23 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Third Edition “. . . an easy-to read introduction to survival analysis which covers the major concepts and techniques of the subject.” —Statistics in Medical Research Updated and expanded to reflect the latest developments, Statistical Methods for Survival Data Analysis, Fourth Edition continues to deliver a comprehensive introduction to the most commonly-used methods for analyzing survival data. Authored by a uniquely well-qualified author team, the Fourth Edition is a critically acclaimed guide to statistical methods with applications in clinical trials, epidemiology, areas of business, and the social sciences. The book features many real-world examples to illustrate applications within these various fields, although special consideration is given to the study of survival data in biomedical sciences. Emphasizing the latest research and providing the most up-to-date information regarding software applications in the field, Statistical Methods for Survival Data Analysis, Fourth Edition also includes: Marginal and random effect models for analyzing correlated censored or uncensored data Multiple types of two-sample and K-sample comparison analysis Updated treatment of parametric methods for regression model fitting with a new focus on accelerated failure time models Expanded coverage of the Cox proportional hazards model Exercises at the end of each chapter to deepen knowledge of the presented material Statistical Methods for Survival Data Analysis is an ideal text for upper-undergraduate and graduate-level courses on survival data analysis. The book is also an excellent resource for biomedical investigators, statisticians, and epidemiologists, as well as researchers in every field in which the analysis of survival data plays a role.

Book An Introduction to Statistical Methods and Data Analysis

Download or read book An Introduction to Statistical Methods and Data Analysis written by R. Lyman Ott and published by Cengage Learning. This book was released on 2010-02-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides worked-out solutions to odd-numbered exercises.

Book Statistical Methods for Evaluating Safety in Medical Product Development

Download or read book Statistical Methods for Evaluating Safety in Medical Product Development written by A. Lawrence Gould and published by John Wiley & Sons. This book was released on 2015-02-23 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Book Statistical Methods

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.

Book Quantitative Evaluation of Safety in Drug Development

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.

Book Statistical Methods and Modeling and Safety Data  Analysis  and Evaluation

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.

Book Statistical Methods  Safety Data  Analysis  and Evaluation  2007

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:

Book Statistical Methods for Categorical Data Analysis

Download or read book Statistical Methods for Categorical Data Analysis written by Daniel Powers and published by Emerald Group Publishing. This book was released on 2008-11-13 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to methods and models for categorical data analysis and their applications in social science research. Companion website also available, at https://webspace.utexas.edu/dpowers/www/

Book Health  Safety  and Environmental Data Analysis

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 1997-10-23 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.

Book Medical Product Safety Evaluation

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.

Book Statistical Data Analysis

Download or read book Statistical Data Analysis written by Glen Cowan and published by Oxford University Press. This book was released on 1998 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a guide to the practical application of statistics in data analysis as typically encountered in the physical sciences. It is primarily addressed at students and professionals who need to draw quantitative conclusions from experimental data. Although most of the examples are takenfrom particle physics, the material is presented in a sufficiently general way as to be useful to people from most branches of the physical sciences. The first part of the book describes the basic tools of data analysis: concepts of probability and random variables, Monte Carlo techniques,statistical tests, and methods of parameter estimation. The last three chapters are somewhat more specialized than those preceding, covering interval estimation, characteristic functions, and the problem of correcting distributions for the effects of measurement errors (unfolding).

Book Handbook of Statistical Methods for Randomized Controlled Trials

Download or read book Handbook of Statistical Methods for Randomized Controlled Trials written by KyungMann Kim and published by CRC Press. This book was released on 2021-08-23 with total page 655 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

Book Advances in Statistical Methods for the Health Sciences

Download or read book Advances in Statistical Methods for the Health Sciences written by Jean-Louis Auget and published by Springer Science & Business Media. This book was released on 2007-08-08 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical methods have become an increasingly important and integral part of research in the health sciences. Many sophisticated methodologies have been developed for specific applications and problems. This self-contained comprehensive volume covers a wide range of topics pertaining to new statistical methods in the health sciences, including epidemiology, pharmacovigilance, quality of life, survival analysis, and genomics. The book will serve the health science community as well as practitioners, researchers, and graduate students in applied probability, statistics, and biostatistics.

Book Drug Safety Evaluation

    Book Details:
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release : 2009-06-17
  • ISBN : 0470464097
  • Pages : 1196 pages

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evaluation Second Edition Shayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.