Encyclopedia of Biopharmaceutical Statistics - Four Volume Set


Book Description

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.




Analysis of Variance for Random Models


Book Description

Analysis of variance (ANOVA) models have become widely used tools and play a fundamental role in much of the application of statistics today. In particular, ANOVA models involving random effects have found widespread application to experimental design in a variety of fields requiring measurements of variance, including agriculture, biology, animal breeding, applied genetics, econometrics, quality control, medicine, engineering, and social sciences. This two-volume work is a comprehensive presentation of different methods and techniques for point estimation, interval estimation, and tests of hypotheses for linear models involving random effects. Both Bayesian and repeated sampling procedures are considered. Volume I examines models with balanced data (orthogonal models); Volume II studies models with unbalanced data (nonorthogonal models). Features and Topics: * Systematic treatment of the commonly employed crossed and nested classification models used in analysis of variance designs * Detailed and thorough discussion of certain random effects models not commonly found in texts at the introductory or intermediate level * Numerical examples to analyze data from a wide variety of disciplines * Many worked examples containing computer outputs from standard software packages such as SAS, SPSS, and BMDP for each numerical example * Extensive exercise sets at the end of each chapter * Numerous appendices with background reference concepts, terms, and results * Balanced coverage of theory, methods, and practical applications * Complete citations of important and related works at the end of each chapter, as well as an extensive general bibliography Accessible to readers with only a modest mathematical and statistical background, the work will appeal to a broad audience of students, researchers, and practitioners in the mathematical, life, social, and engineering sciences. It may be used as a textbook in upper-level undergraduate and graduate courses, or as a reference for readers interested in the use of random effects models for data analysis.




Journal of the American Statistical Association


Book Description

A scientific and educational journal not only for professional statisticians but also for economists, business executives, research directors, government officials, university professors, and others who are seriously interested in the application of statistical methods to practical problems, in the development of more useful methods, and in the improvement of basic statistical data.




Variance Components


Book Description

WILEY-INTERSCIENCE PAPERBACK SERIES The Wiley-Interscience Paperback Series consists of selected books that have been made more accessible to consumers in an effort to increase global appeal and general circulation. With these new unabridged softcover volumes, Wiley hopes to extend the lives of these works by making them available to future generations of statisticians, mathematicians, and scientists. ". . .Variance Components is an excellent book. It is organized and well written, and provides many references to a variety of topics. I recommend it to anyone with interest in linear models." —Journal of the American Statistical Association "This book provides a broad coverage of methods for estimating variance components which appeal to students and research workers . . . The authors make an outstanding contribution to teaching and research in the field of variance component estimation." —Mathematical Reviews "The authors have done an excellent job in collecting materials on a broad range of topics. Readers will indeed gain from using this book . . . I must say that the authors have done a commendable job in their scholarly presentation." —Technometrics This book focuses on summarizing the variability of statistical data known as the analysis of variance table. Penned in a readable style, it provides an up-to-date treatment of research in the area. The book begins with the history of analysis of variance and continues with discussions of balanced data, analysis of variance for unbalanced data, predictions of random variables, hierarchical models and Bayesian estimation, binary and discrete data, and the dispersion mean model.




NBS Special Publication


Book Description




Methods and Applications of Statistics in Clinical Trials, Volume 2


Book Description

Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials







Asymptotic Analysis of Mixed Effects Models


Book Description

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.




Statistical Applications in Process Control


Book Description

This work presents significant advances and new methods both in statistical process control and experimental design. It addresses the management of process monitoring and experimental design, discusses the relationship between control charting and hypothesis testing, provides a new index for process capability studies, offers practical guidelines for the design of experiments, and more.