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基本説明
Includes expanded sections on nonparametric statistics and Bayesian methods, a complete revision of the chapter on binary and categorical data, data from psychological experiments, and more.
Full Description
The first edition of Design and Analysis of Cross-Over Trials quickly became the standard reference on the subject and has remained so for more than 12 years. In that time, however, the use of cross-over trials has grown rapidly, particularly in the pharmaceutical arena, and researchers have made a number of advances in both the theory and methods applicable to these trials. Completely revised and updated, the long-awaited second edition of this classic text retains its predecessor's careful balance of theory and practice while incorporating new approaches, more data sets, and a broader scope. Enhancements in the second edition include: A new chapter on bioequivalence Recently developed methods for analyzing longitudinal continuous and categorical data Real-world examples using the SAS system A comprehensive catalog of designs, datasets, and SAS programs available on a companion Web site at www.crcpress.com The authors' exposition gives a clear, unified account of the design and analysis of cross-over trials from a statistical perspective along with their methodological underpinnings.With SAS programs and a thorough treatment of design issues, Design and Analysis of Cross-Over Trials, Second Edition sets a new standard for texts in this area and undoubtedly will be of direct practical value for years to come.
Contents
INTRODUCTION What is a Cross-Over Trial? With which Sort of Cross-Over Trial are We Concerned? Why Do Cross-Over Trials Need Special Consideration? A Brief History Notation, Models and Analysis Aims of this Book Structure of the Book THE 2 x 2 CROSS-OVER TRIAL Introduction Plotting the Data The Analysis Using t-Tests Sample Size Calculations The Analysis of Variance Aliasing of Effects Consequences of preliminary testing Analyzing the residuals A Bayesian Analysis of the 2 x 2 Trial The Use of Baseline Measurements The Use of Covariates Nonparametric Analysis Binary Data HIGHER-ORDER DESIGNS FOR TWO TREATMENTS Introduction 'Optimal' Designs Balaam's Design for Two Treatments The Effect of Preliminary Testing in Balaam's Design Three-Period Designs with Two Sequences Three-Period Designs with Four Sequences A Three-Period Six-Sequence Design Which Three-Period Design to Use? Four-Period Designs with Two Sequences Four-Period Designs with Four Sequences Four-Period Designs with Six Sequences Which Four-Period Design to Use? Which Two-Treatment Design to Use? DESIGNING CROSS-OVER TRIALS FOR THREE OR MORE TREATMENTS Introduction Variance-Balanced Designs Optimality Results for Cross-Over Designs Which Variance Balanced Design to Use? Partially Balanced Designs Comparing Test Treatments to a Control Factorial Treatment Combinations Extending the Simple Model for Carry-Over Effects Computer Search Algorithms ANALYSIS OF CONTINUOUS DATA Introduction The Fixed Subject Effects Model The Random Subject Effects Model Analyses for Higher-Order Two-Treatment Designs The General Linear Mixed Model Analysis of Repeated Measurements within Periods Cross-Over Data as Repeated Measurements Case Study: an Analysis of a Trial with Many Periods ANALYSIS OF CATEGORICAL DATA Introduction Binary Data: Subject Effect Models Binary Data: Marginal Models Categorical Data Further Topics BIOEQUIVALENCE TRIALS What is Bioequivalence Testing for Average Bioequivalence Power and Sample Size for ABE in the 2 x 2 Design Individual Bioequivalence Population Bioequivalence ABE for a Replicate Design Kullback-Leibler Divergence for Evaluating Bioequivalence Modelling Pharmacokinetic Data APPENDICES Least Squares Estimation SAS Code for Assessing ABEm IBE, and PBE in Replicate Cross-Over Trials REFERENCES
