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Design and Analysis of Cross-Over Trials, Second Edition Byron Jones (Novartis Pharma AG, Basel, Switzerland)

Design and Analysis of Cross-Over Trials, Second Edition By Byron Jones (Novartis Pharma AG, Basel, Switzerland)

Design and Analysis of Cross-Over Trials, Second Edition by Byron Jones (Novartis Pharma AG, Basel, Switzerland)


Summary

Including a new chapter on application of cross over trials in psychology, this volume discusses such subjects as higher order designs for two treatments, designs and analyses for three or more treatments, and the analysis of repeated measurements within periods.

Design and Analysis of Cross-Over Trials, Second Edition Summary

Design and Analysis of Cross-Over Trials, Second Edition by Byron Jones (Novartis Pharma AG, Basel, Switzerland)

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.

Table of 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

Additional information

GOR013145973
9780412606403
0412606402
Design and Analysis of Cross-Over Trials, Second Edition by Byron Jones (Novartis Pharma AG, Basel, Switzerland)
Used - Very Good
Hardback
Chapman and Hall
20030312
408
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
This is a used book - there is no escaping the fact it has been read by someone else and it will show signs of wear and previous use. Overall we expect it to be in very good condition, but if you are not entirely satisfied please get in touch with us

Customer Reviews - Design and Analysis of Cross-Over Trials, Second Edition