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The purpose of this book is to provide a general guide to statistical methods used in the pharmaceutical industry, and to illustrate how to use S-PLUS to implement these methods. Specifically, the goal is to: *Illustrate statistical applications in the pharmaceutical industry; *Illustrate how the statistical applications can be carried out using S-PLUS; *Illustrate why S-PLUS is a useful software package for carrying out these applications; *Discuss the results and implications of a particular application; The target audience for this book is very broad, including: *Graduate students in biostatistics; *Statisticians who are involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the indsutry that they may not be familiar with; *Statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
Introduction.- Analysis of Large Designed Experiments Using Trellis Graphics and Tree-Based Regression.- Using S-PLUS to Perform Sample Size Calculations.- Design and Analysis of Two-Period Cross-Over Trials.- Analysis of Pharmacokinetic Studies.- Patient Compliance and Its Impact on Steady State Pharmacokinetics.- Survival Analysis to Compare Two Treatments in a Large Phase III Trial.- Using S-PLUS and SAS for ANOVA and Contrasts.- Using S-PLUS to Construct Design-Based Permutation Tests for a Variety of Endpoints and Designs in Phase III Clinical Trials.- Graphical Presentation of Single Patient Results.- Using The Seattle Angine Questionnaire as a Primary Outcome in Clinical Trials.- Health Economics.- Statistical Methodology and S- PLUS Programming for the Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production.- Acceptance Sampling Using S-PLUS.
From the reviews: STATISTICAL METHODS IN MEDICAL RESEARCH AN INTERNATIONAL REVIEW JOURNAL "...this book is extremely good and highly recommended to statisticians involved in the drug development process." "The book has a dual purpose. First, it contains examples of statistics in practice and includes interesting real-life examples ! . The second purpose of the book is to promote the use of S-Plus, by showing what can be done with this software, and illustrating its use ! . this is a very valuable book of case studies. Managers of Biometrics groups should ensure their staff have access to a copy and statistics consultants will need a copy of their own." (Tim Auton, Journal of Applied Statistics, Vol. 30 (1), 2003) "Most of the chapters are written from a procedural perspective, describing the task to be done, showing the S-PLUS code required to conduct the task, and then displaying the S-PLUS results. ! For a reader already sold on S-PLUS and looking for ways to apply it in his or her work, this book will be appealing. ! The book will help pharmaceutical statisticians implement S-PLUS in their work if they are new to S-PLUS." (Brian J. Eastwood, Journal of the American Statistical Association, Issue March, 2003) "Each one of the chapters begins with a short introduction to the subject, followed by background information on each source of data. ... and finishes with related references and an appendix with S-PLUS code. The latter is of major benefit to readers. It is very clearly set out with macros that cover a wide range of graphics and aspects of statistical analysis. ! this book is extremely good and highly recommended to statisticians involved in the drug development process." (Vasilis Nikolaou, Statistical Methods in Medical Research, Vol. 11 (2), 2002)