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Quantitative Evaluation of Safety in Drug Development
State-of-the-Art Methods for Drug Safety AssessmentResponding 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 deve
Patient-Reported Outcomes
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the healt
Mixed Effects Models for the Population Approach
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical, count, and time-to-event data. This leads to the use of generic methods, such as the stochastic approximation of ...
Inference Principles for Biostatisticians
Designed for students training to become biostatisticians as well as practicing biostatisticians, Inference Principles for Biostatisticians presents the theoretical and conceptual foundations of biostatistics. It covers the theoretical underpinnings essential to understanding subsequent core methodologies in the field. Drawing on his extensive experience teaching graduate-level biostatistics courses and working in the pharmaceutical industry, the author explains the main principles of statistical inference with many examples and exercises. Extended examples illustrate key concepts in depth using a specific biostatistical context. In addition, the author uses simulation to reinforce the repeated sampling interpretation of numerous statistical concepts. Reducing the computational complexities, he provides simple R functions for conducting simulation studies. This text gives graduate students with diverse backgrounds across the health, medical, social, and mathematical sciences a solid, unified foundation in the principles of statistical inference. This groundwork will lead students to develop a thorough understanding of biostatistical methodology.
Noninferiority Testing in Clinical Trials
Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.
Advances in Bayesian Networks
In recent years probabilistic graphical models, especially Bayesian networks and decision graphs, have experienced significant theoretical development within areas such as artificial intelligence and statistics. This carefully edited monograph is a compendium of the most recent advances in the area of probabilistic graphical models such as decision graphs, learning from data and inference. It presents a survey of the state of the art of specific topics of recent interest of Bayesian Networks, including approximate propagation, abductive inferences, decision graphs, and applications of influence. In addition, Advances in Bayesian Networks presents a careful selection of applications of probabilistic graphical models to various fields such as speech recognition, meteorology or information retrieval.
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas...
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Corning
Lenses for railroad lanterns, cut glass for the White House table, Thomas Edison's first light bulb-the glass for all of these was made in Corning, the glass capital of America, the Crystal City. From 1880 to World War I, newfound wealth sparked a spending and building boom that shaped the city. Corning recaptures the city's gilded age, the boom days when tax-free fortunes could be made-and lost-overnight. Vintage photographs show elephants and buffalo parading down Market Street, the Drake family giving recitals on its home pipe organ, churches and public buildings rising, carriages giving way to motorcars, and huge summer homes springing up on the Finger Lakes.
Adaptive Design Theory and Implementation Using SAS and R, Second Edition
Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More ana...
