Incomplete Data In Generalized Linear Models

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Flexible Imputation of Missing Data, Second Edition

Author : Stef van Buuren
Publisher : CRC Press
ISBN 13 : 0429960352
Total Pages : 444 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Flexible Imputation of Missing Data, Second Edition by : Stef van Buuren

Download or read book Flexible Imputation of Missing Data, Second Edition written by Stef van Buuren and published by CRC Press. This book was released on 2018-07-17 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Missing data pose challenges to real-life data analysis. Simple ad-hoc fixes, like deletion or mean imputation, only work under highly restrictive conditions, which are often not met in practice. Multiple imputation replaces each missing value by multiple plausible values. The variability between these replacements reflects our ignorance of the true (but missing) value. Each of the completed data set is then analyzed by standard methods, and the results are pooled to obtain unbiased estimates with correct confidence intervals. Multiple imputation is a general approach that also inspires novel solutions to old problems by reformulating the task at hand as a missing-data problem. This is the second edition of a popular book on multiple imputation, focused on explaining the application of methods through detailed worked examples using the MICE package as developed by the author. This new edition incorporates the recent developments in this fast-moving field. This class-tested book avoids mathematical and technical details as much as possible: formulas are accompanied by verbal statements that explain the formula in accessible terms. The book sharpens the reader’s intuition on how to think about missing data, and provides all the tools needed to execute a well-grounded quantitative analysis in the presence of missing data.

Incomplete Data in Generalized Linear Models

Author : Joseph George Ibrahim
Publisher :
ISBN 13 :
Total Pages : 570 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Incomplete Data in Generalized Linear Models by : Joseph George Ibrahim

Download or read book Incomplete Data in Generalized Linear Models written by Joseph George Ibrahim and published by . This book was released on 1988 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Statistical Methods for Handling Incomplete Data

Author : Jae Kwang Kim
Publisher : CRC Press
ISBN 13 : 1000466299
Total Pages : 380 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Statistical Methods for Handling Incomplete Data by : Jae Kwang Kim

Download or read book Statistical Methods for Handling Incomplete Data written by Jae Kwang Kim and published by CRC Press. This book was released on 2021-11-19 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to recent theoretical findings and advances in statistical computing, there has been a rapid development of techniques and applications in the area of missing data analysis. Statistical Methods for Handling Incomplete Data covers the most up-to-date statistical theories and computational methods for analyzing incomplete data. Features Uses the mean score equation as a building block for developing the theory for missing data analysis Provides comprehensive coverage of computational techniques for missing data analysis Presents a rigorous treatment of imputation techniques, including multiple imputation fractional imputation Explores the most recent advances of the propensity score method and estimation techniques for nonignorable missing data Describes a survey sampling application Updated with a new chapter on Data Integration Now includes a chapter on Advanced Topics, including kernel ridge regression imputation and neural network model imputation The book is primarily aimed at researchers and graduate students from statistics, and could be used as a reference by applied researchers with a good quantitative background. It includes many real data examples and simulated examples to help readers understand the methodologies.

Multiple Imputation of Missing Data Using SAS

Author : Patricia Berglund
Publisher : SAS Institute
ISBN 13 : 162959203X
Total Pages : 328 pages
Book Rating : 4.6/5 (295 download)

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Book Synopsis Multiple Imputation of Missing Data Using SAS by : Patricia Berglund

Download or read book Multiple Imputation of Missing Data Using SAS written by Patricia Berglund and published by SAS Institute. This book was released on 2014-07-01 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Find guidance on using SAS for multiple imputation and solving common missing data issues. Multiple Imputation of Missing Data Using SAS provides both theoretical background and constructive solutions for those working with incomplete data sets in an engaging example-driven format. It offers practical instruction on the use of SAS for multiple imputation and provides numerous examples that use a variety of public release data sets with applications to survey data. Written for users with an intermediate background in SAS programming and statistics, this book is an excellent resource for anyone seeking guidance on multiple imputation. The authors cover the MI and MIANALYZE procedures in detail, along with other procedures used for analysis of complete data sets. They guide analysts through the multiple imputation process, including evaluation of missing data patterns, choice of an imputation method, execution of the process, and interpretation of results. Topics discussed include how to deal with missing data problems in a statistically appropriate manner, how to intelligently select an imputation method, how to incorporate the uncertainty introduced by the imputation process, and how to incorporate the complex sample design (if appropriate) through use of the SAS SURVEY procedures. Discover the theoretical background and see extensive applications of the multiple imputation process in action. This book is part of the SAS Press program.

Asymptotic Analysis of Mixed Effects Models

Author : Jiming Jiang
Publisher : CRC Press
ISBN 13 : 1498700462
Total Pages : 252 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Asymptotic Analysis of Mixed Effects Models by : Jiming Jiang

Download or read book Asymptotic Analysis of Mixed Effects Models written by Jiming Jiang and published by CRC Press. This book was released on 2017-09-19 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Large sample techniques are fundamental to all fields of statistics. Mixed effects models, including linear mixed models, generalized linear mixed models, non-linear mixed effects models, and non-parametric mixed effects models are complex models, yet, these models are extensively used in practice. This monograph provides a comprehensive account of asymptotic analysis of mixed effects models. The monograph is suitable for researchers and graduate students who wish to learn about asymptotic tools and research problems in mixed effects models. It may also be used as a reference book for a graduate-level course on mixed effects models, or asymptotic analysis.

Mixed Effects Models for Complex Data

Author : Lang Wu
Publisher : CRC Press
ISBN 13 : 9781420074086
Total Pages : 431 pages
Book Rating : 4.0/5 (74 download)

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Book Synopsis Mixed Effects Models for Complex Data by : Lang Wu

Download or read book Mixed Effects Models for Complex Data written by Lang Wu and published by CRC Press. This book was released on 2009-11-11 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although standard mixed effects models are useful in a range of studies, other approaches must often be used in correlation with them when studying complex or incomplete data. Mixed Effects Models for Complex Data discusses commonly used mixed effects models and presents appropriate approaches to address dropouts, missing data, measurement errors, censoring, and outliers. For each class of mixed effects model, the author reviews the corresponding class of regression model for cross-sectional data. An overview of general models and methods, along with motivating examples After presenting real data examples and outlining general approaches to the analysis of longitudinal/clustered data and incomplete data, the book introduces linear mixed effects (LME) models, generalized linear mixed models (GLMMs), nonlinear mixed effects (NLME) models, and semiparametric and nonparametric mixed effects models. It also includes general approaches for the analysis of complex data with missing values, measurement errors, censoring, and outliers. Self-contained coverage of specific topics Subsequent chapters delve more deeply into missing data problems, covariate measurement errors, and censored responses in mixed effects models. Focusing on incomplete data, the book also covers survival and frailty models, joint models of survival and longitudinal data, robust methods for mixed effects models, marginal generalized estimating equation (GEE) models for longitudinal or clustered data, and Bayesian methods for mixed effects models. Background material In the appendix, the author provides background information, such as likelihood theory, the Gibbs sampler, rejection and importance sampling methods, numerical integration methods, optimization methods, bootstrap, and matrix algebra. Failure to properly address missing data, measurement errors, and other issues in statistical analyses can lead to severely biased or misleading results. This book explores the biases that arise when naïve methods are used and shows which approaches should be used to achieve accurate results in longitudinal data analysis.

Applied Missing Data Analysis

Author : Craig K. Enders
Publisher : Guilford Publications
ISBN 13 : 1462549861
Total Pages : 563 pages
Book Rating : 4.4/5 (625 download)

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Book Synopsis Applied Missing Data Analysis by : Craig K. Enders

Download or read book Applied Missing Data Analysis written by Craig K. Enders and published by Guilford Publications. This book was released on 2022-08-31 with total page 563 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The most user-friendly and authoritative resource on missing data has been completely revised to make room for the latest developments that make handling missing data more effective. The second edition includes new methods based on factored regressions, newer model-based imputation strategies, and innovations in Bayesian analysis. State-of-the-art technical literature on missing data is translated into accessible guidelines for applied researchers and graduate students. The second edition takes an even, three-pronged approach to maximum likelihood estimation (MLE), Bayesian estimation as an alternative to MLE, and multiple imputation. Consistently organized chapters explain the rationale and procedural details for each technique and illustrate the analyses with engaging worked-through examples on such topics as young adult smoking, employee turnover, and chronic pain. The companion website includes datasets and analysis examples from the book, up-to-date software information, and other resources. Subject areas/Key words: advanced quantitative methods, management, survey, longitudinal, structural equation modeling, handling, how to handle, incomplete, multivariate, social research, behavioral sciences, statistical techniques, textbooks, seminars, doctoral courses, multiple imputation, models, MCAR, MNAR, Bayesian Audience: Researchers and graduate students in psychology, education, management, family studies, public health, sociology, and political science"--

Univariate and Multivariate General Linear Models

Author : Kevin Kim
Publisher : CRC Press
ISBN 13 : 9781584886341
Total Pages : 576 pages
Book Rating : 4.8/5 (863 download)

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Book Synopsis Univariate and Multivariate General Linear Models by : Kevin Kim

Download or read book Univariate and Multivariate General Linear Models written by Kevin Kim and published by CRC Press. This book was released on 2006-10-11 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviewing the theory of the general linear model (GLM) using a general framework, Univariate and Multivariate General Linear Models: Theory and Applications with SAS, Second Edition presents analyses of simple and complex models, both univariate and multivariate, that employ data sets from a variety of disciplines, such as the social and behavioral sciences. With revised examples that include options available using SAS 9.0, this expanded edition divides theory from applications within each chapter. Following an overview of the GLM, the book introduces unrestricted GLMs to analyze multiple regression and ANOVA designs as well as restricted GLMs to study ANCOVA designs and repeated measurement designs. Extensions of these concepts include GLMs with heteroscedastic errors that encompass weighted least squares regression and categorical data analysis, and multivariate GLMs that cover multivariate regression analysis, MANOVA, MANCOVA, and repeated measurement data analyses. The book also analyzes double multivariate linear, growth curve, seeming unrelated regression (SUR), restricted GMANOVA, and hierarchical linear models. New to the Second Edition Two chapters on finite intersection tests and power analysis that illustrates the experimental GLMPOWER procedure Expanded theory of unrestricted general linear, multivariate general linear, SUR, and restricted GMANOVA models to comprise recent developments Expanded material on missing data to include multiple imputation and the EM algorithm Applications of MI, MIANALYZE, TRANSREG, and CALIS procedures A practical introduction to GLMs, Univariate and Multivariate General Linear Models demonstrates how to fully grasp the generality of GLMs by discussing them within a general framework.

Statistical Analysis with Missing Data

Author : Roderick J. A. Little
Publisher : John Wiley & Sons
ISBN 13 : 1118596013
Total Pages : 465 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Statistical Analysis with Missing Data by : Roderick J. A. Little

Download or read book Statistical Analysis with Missing Data written by Roderick J. A. Little and published by John Wiley & Sons. This book was released on 2019-03-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: An up-to-date, comprehensive treatment of a classic text on missing data in statistics The topic of missing data has gained considerable attention in recent decades. This new edition by two acknowledged experts on the subject offers an up-to-date account of practical methodology for handling missing data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing data mechanism, and then they apply the theory to a wide range of important missing data problems. Statistical Analysis with Missing Data, Third Edition starts by introducing readers to the subject and approaches toward solving it. It looks at the patterns and mechanisms that create the missing data, as well as a taxonomy of missing data. It then goes on to examine missing data in experiments, before discussing complete-case and available-case analysis, including weighting methods. The new edition expands its coverage to include recent work on topics such as nonresponse in sample surveys, causal inference, diagnostic methods, and sensitivity analysis, among a host of other topics. An updated “classic” written by renowned authorities on the subject Features over 150 exercises (including many new ones) Covers recent work on important methods like multiple imputation, robust alternatives to weighting, and Bayesian methods Revises previous topics based on past student feedback and class experience Contains an updated and expanded bibliography The authors were awarded The Karl Pearson Prize in 2017 by the International Statistical Institute, for a research contribution that has had profound influence on statistical theory, methodology or applications. Their work "has been no less than defining and transforming." (ISI) Statistical Analysis with Missing Data, Third Edition is an ideal textbook for upper undergraduate and/or beginning graduate level students of the subject. It is also an excellent source of information for applied statisticians and practitioners in government and industry.

Handbook of Missing Data Methodology

Author : Geert Molenberghs
Publisher : CRC Press
ISBN 13 : 1439854610
Total Pages : 600 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Handbook of Missing Data Methodology by : Geert Molenberghs

Download or read book Handbook of Missing Data Methodology written by Geert Molenberghs and published by CRC Press. This book was released on 2014-11-06 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Missing data affect nearly every discipline by complicating the statistical analysis of collected data. But since the 1990s, there have been important developments in the statistical methodology for handling missing data. Written by renowned statisticians in this area, Handbook of Missing Data Methodology presents many methodological advances and the latest applications of missing data methods in empirical research. Divided into six parts, the handbook begins by establishing notation and terminology. It reviews the general taxonomy of missing data mechanisms and their implications for analysis and offers a historical perspective on early methods for handling missing data. The following three parts cover various inference paradigms when data are missing, including likelihood and Bayesian methods; semi-parametric methods, with particular emphasis on inverse probability weighting; and multiple imputation methods. The next part of the book focuses on a range of approaches that assess the sensitivity of inferences to alternative, routinely non-verifiable assumptions about the missing data process. The final part discusses special topics, such as missing data in clinical trials and sample surveys as well as approaches to model diagnostics in the missing data setting. In each part, an introduction provides useful background material and an overview to set the stage for subsequent chapters. Covering both established and emerging methodologies for missing data, this book sets the scene for future research. It provides the framework for readers to delve into research and practical applications of missing data methods.

Missing Data and Small-Area Estimation

Author : Nicholas T. Longford
Publisher : Springer Science & Business Media
ISBN 13 : 9781852337605
Total Pages : 384 pages
Book Rating : 4.3/5 (376 download)

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Book Synopsis Missing Data and Small-Area Estimation by : Nicholas T. Longford

Download or read book Missing Data and Small-Area Estimation written by Nicholas T. Longford and published by Springer Science & Business Media. This book was released on 2005-08-05 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book evolved from lectures, courses and workshops on missing data and small-area estimation that I presented during my tenure as the ?rst C- pion Fellow (2000–2002). For the Fellowship I proposed these two topics as areas in which the academic statistics could contribute to the development of government statistics, in exchange for access to the operational details and background that would inform the direction and sharpen the focus of a- demic research. After a few years of involvement, I have come to realise that the separation of ‘academic’ and ‘industrial’ statistics is not well suited to either party, and their integration is the key to progress in both branches. Most of the work on this monograph was done while I was a visiting l- turer at Massey University, Palmerston North, New Zealand. The hospitality and stimulating academic environment of their Institute of Information S- ence and Technology is gratefully acknowledged. I could not name all those who commented on my lecture notes and on the presentations themselves; apart from them, I want to thank the organisers and silent attendees of all the events, and, with a modicum of reluctance, the ‘grey ?gures’ who kept inquiring whether I was any nearer the completion of whatever stage I had been foolish enough to attach a date.

Longitudinal Data Analysis

Author : Garrett Fitzmaurice
Publisher : CRC Press
ISBN 13 : 142001157X
Total Pages : 633 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Longitudinal Data Analysis by : Garrett Fitzmaurice

Download or read book Longitudinal Data Analysis written by Garrett Fitzmaurice and published by CRC Press. This book was released on 2008-08-11 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although many books currently available describe statistical models and methods for analyzing longitudinal data, they do not highlight connections between various research threads in the statistical literature. Responding to this void, Longitudinal Data Analysis provides a clear, comprehensive, and unified overview of state-of-the-art theory

Applied Missing Data Analysis in the Health Sciences

Author : Xiao-Hua Zhou
Publisher : John Wiley & Sons
ISBN 13 : 1118573641
Total Pages : 260 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Applied Missing Data Analysis in the Health Sciences by : Xiao-Hua Zhou

Download or read book Applied Missing Data Analysis in the Health Sciences written by Xiao-Hua Zhou and published by John Wiley & Sons. This book was released on 2014-05-19 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applied Missing Data Analysis in the Health Sciences A modern and practical guide to the essential concepts and ideas for analyzing data with missing observations in the field of biostatistics With an emphasis on hands-on applications, Applied Missing Data Analysis in the Health Sciences outlines the various statistical methods for the analysis of missing data. The authors acknowledge the limitations of established techniques and provide newly-developed methods with concrete applications in areas such as causal inference. Organized by types of data, chapter coverage begins with an overall introduction to the existence and limitations of missing data and continues into techniques for missing data inference, including likelihood-based, weighted GEE, multiple imputation, and Bayesian methods. The book subsequently covers cross-sectional, longitudinal, hierarchical, survival data. In addition, Applied Missing Data Analysis in the Health Sciences features: Multiple data sets that can be replicated using SAS®, Stata®, R, and WinBUGS software packages Numerous examples of case studies to illustrate real-world scenarios and demonstrate applications of discussed methodologies Detailed appendices to guide readers through the use of the presented data in various software environments Applied Missing Data Analysis in the Health Sciences is an excellent textbook for upper-undergraduate and graduate-level biostatistics courses as well as an ideal resource for health science researchers and applied statisticians.

Generalized Linear Models with Random Effects

Author : Youngjo Lee
Publisher : CRC Press
ISBN 13 : 1420011340
Total Pages : 411 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Generalized Linear Models with Random Effects by : Youngjo Lee

Download or read book Generalized Linear Models with Random Effects written by Youngjo Lee and published by CRC Press. This book was released on 2006-07-13 with total page 411 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since their introduction in 1972, generalized linear models (GLMs) have proven useful in the generalization of classical normal models. Presenting methods for fitting GLMs with random effects to data, Generalized Linear Models with Random Effects: Unified Analysis via H-likelihood explores a wide range of applications, including combining information over trials (meta-analysis), analysis of frailty models for survival data, genetic epidemiology, and analysis of spatial and temporal models with correlated errors. Written by pioneering authorities in the field, this reference provides an introduction to various theories and examines likelihood inference and GLMs. The authors show how to extend the class of GLMs while retaining as much simplicity as possible. By maximizing and deriving other quantities from h-likelihood, they also demonstrate how to use a single algorithm for all members of the class, resulting in a faster algorithm as compared to existing alternatives. Complementing theory with examples, many of which can be run by using the code supplied on the accompanying CD, this book is beneficial to statisticians and researchers involved in the above applications as well as quality-improvement experiments and missing-data analysis.

ISS-2012 Proceedings Volume On Longitudinal Data Analysis Subject to Measurement Errors, Missing Values, and/or Outliers

Author : Brajendra C. Sutradhar
Publisher : Springer Science & Business Media
ISBN 13 : 146146871X
Total Pages : 224 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis ISS-2012 Proceedings Volume On Longitudinal Data Analysis Subject to Measurement Errors, Missing Values, and/or Outliers by : Brajendra C. Sutradhar

Download or read book ISS-2012 Proceedings Volume On Longitudinal Data Analysis Subject to Measurement Errors, Missing Values, and/or Outliers written by Brajendra C. Sutradhar and published by Springer Science & Business Media. This book was released on 2013-08-13 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This proceedings volume contains nine selected papers that were presented in the International Symposium in Statistics, 2012 held at Memorial University from July 16 to 18. These nine papers cover three different areas for longitudinal data analysis, four dealing with longitudinal data subject to measurement errors, four on incomplete longitudinal data analysis, and the last one for inferences for longitudinal data subject to outliers. Unlike in the independence setup, the inferences in measurement errors, missing values, and/or outlier models, are not adequately discussed in the longitudinal setup. The papers in the present volume provide details on successes and further challenges in these three areas for longitudinal data analysis. This volume is the first outlet with current research in three important areas in the longitudinal setup. The nine papers presented in three parts clearly reveal the similarities and differences in inference techniques used for three different longitudinal setups. Because the research problems considered in this volume are encountered in many real life studies in biomedical, clinical, epidemiology, socioeconomic, econometrics, and engineering fields, the volume should be useful to the researchers including graduate students in these areas.

Handbook of Data Analysis

Author : Melissa A Hardy
Publisher : SAGE
ISBN 13 : 1446203441
Total Pages : 729 pages
Book Rating : 4.4/5 (462 download)

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Book Synopsis Handbook of Data Analysis by : Melissa A Hardy

Download or read book Handbook of Data Analysis written by Melissa A Hardy and published by SAGE. This book was released on 2009-06-17 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: ′This book provides an excellent reference guide to basic theoretical arguments, practical quantitative techniques and the methodologies that the majority of social science researchers are likely to require for postgraduate study and beyond′ - Environment and Planning ′The book provides researchers with guidance in, and examples of, both quantitative and qualitative modes of analysis, written by leading practitioners in the field. The editors give a persuasive account of the commonalities of purpose that exist across both modes, as well as demonstrating a keen awareness of the different things that each offers the practising researcher′ - Clive Seale, Brunel University ′With the appearance of this handbook, data analysts no longer have to consult dozens of disparate publications to carry out their work. The essential tools for an intelligent telling of the data story are offered here, in thirty chapters written by recognized experts. ′ - Michael Lewis-Beck, F Wendell Miller Distinguished Professor of Political Science, University of Iowa ′This is an excellent guide to current issues in the analysis of social science data. I recommend it to anyone who is looking for authoritative introductions to the state of the art. Each chapter offers a comprehensive review and an extensive bibliography and will be invaluable to researchers wanting to update themselves about modern developments′ - Professor Nigel Gilbert, Pro Vice-Chancellor and Professor of Sociology, University of Surrey This is a book that will rapidly be recognized as the bible for social researchers. It provides a first-class, reliable guide to the basic issues in data analysis, such as the construction of variables, the characterization of distributions and the notions of inference. Scholars and students can turn to it for teaching and applied needs with confidence. The book also seeks to enhance debate in the field by tackling more advanced topics such as models of change, causality, panel models and network analysis. Specialists will find much food for thought in these chapters. A distinctive feature of the book is the breadth of coverage. No other book provides a better one-stop survey of the field of data analysis. In 30 specially commissioned chapters the editors aim to encourage readers to develop an appreciation of the range of analytic options available, so they can choose a research problem and then develop a suitable approach to data analysis.

Pharmaceutical Statistics Using SAS

Author : Alex Dmitrienko
Publisher : SAS Institute
ISBN 13 : 1599943573
Total Pages : 464 pages
Book Rating : 4.5/5 (999 download)

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Book Synopsis Pharmaceutical Statistics Using SAS by : Alex Dmitrienko

Download or read book Pharmaceutical Statistics Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2007 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.