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Statistical Evaluation of Diagnostic Performance
Statistical evaluation of diagnostic performance in general and Receiver Operating Characteristic (ROC) analysis in particular are important for assessing the performance of medical tests and statistical classifiers, as well as for evaluating predictive models or algorithms. This book presents innovative approaches in ROC analysis, which are releva
Biostatistics: A Computing Approach
The emergence of high-speed computing has facilitated the development of many exciting statistical and mathematical methods in the last 25 years, broadening the landscape of available tools in statistical investigations of complex data. Biostatistics: A Computing Approach focuses on visualization and computational approaches associated with both modern and classical techniques. Furthermore, it promotes computing as a tool for performing both analyses and simulations that can facilitate such understanding. As a practical matter, programs in R and SAS are presented throughout the text. In addition to these programs, appendices describing the basic use of SAS and R are provided. Teaching by exa...
Interval-Censored Time-to-Event Data
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data. Top biostatisticians from academia, biopharmaceutical industries, and government agencies discuss how these advances are impacting clinical trials and biomedical research. Divided into three parts, the book begins with an overview of interval-censored data modeling, including nonparametric estimation, survival functions, regression analysis, multivariate data analysis, competing risks analysis, and other models for interval-censored data. The next part presents interval-censored methods for current status data, Bayesian ...
Statistical Analysis of Human Growth and Development
Statistical Analysis of Human Growth and Development is an accessible and practical guide to a wide range of basic and advanced statistical methods that are useful for studying human growth and development. Designed for nonstatisticians and statisticians new to the analysis of growth and development data, the book collects methods scattered through
Optimal Design for Nonlinear Response Models
Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.
Survival Analysis in Medicine and Genetics
Using real data sets throughout, this text introduces the latest methods for analyzing high-dimensional survival data. With an emphasis on the applications of survival analysis techniques in genetics, it presents a statistical framework for burgeoning research in this area and offers a set of established approaches for statistical analysis. The book reveals a new way of looking at how predictors are associated with censored survival time and extracts novel statistical genetic methods for censored survival time outcome from the vast amount of research results in genomics.
Confidence Intervals for Proportions and Related Measures of Effect Size
Confidence Intervals for Proportions and Related Measures of Effect Size illustrates the use of effect size measures and corresponding confidence intervals as more informative alternatives to the most basic and widely used significance tests. The book provides you with a deep understanding of what happens when these statistical methods are applied in situations far removed from the familiar Gaussian case. Drawing on his extensive work as a statistician and professor at Cardiff University School of Medicine, the author brings together methods for calculating confidence intervals for proportions and several other important measures, including differences, ratios, and nonparametric effect size measures generalizing Mann-Whitney and Wilcoxon tests. He also explains three important approaches to obtaining intervals for related measures. Many examples illustrate the application of the methods in the health and social sciences. Requiring little computational skills, the book offers user-friendly Excel spreadsheets for download at www.crcpress.com, enabling you to easily apply the methods to your own empirical data.
Biosimilars
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf
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.
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...
