Applied Statistics in the Pharmaceutical Industry: With Case Studies Using S-Plus

ISBN-13: 9781441931665 / Angielski / Miękka / 2010 / 514 str.

Steven P. Millard; Andreas Krause

Opis

Each year hundreds of new drugs are approved for the marketplace. The approval of a single new drug is the result of years of screening tens of thousands of compounds, performing pre-clinical research on their effects, and designing, implementing, and analyzing the results of clinical trials. This book provides a general guide to statistical methods used in the pharmaceutical industry, and is aimed at graduate students and researchers who want to know more about statistical applications in all phases of the drug development process. The 19 chapters authored by over 30 statisticians working in the industry follow the general sequence of drug development, from pre-clinical research and saftey assessment to dose finding, safety studies, large clinical trials, analysis of health economic data, and fianlly manufacturing and production. Special topics such as single patient analysis and the impact of patient compliance show the broad spectrum of applications of data analysis methods. Each chapter illustrates a practical problem using data from actual studies by describing the study, the data, the methods, and the results. All of the analyses are done with S-PLUS, and the data and code are provided both in appendices to the chapters and on the companion Springer-Verlag web site, making it possible to reproduce the results and extend the analyses. Prior knowledge of the software is not required to follow the analyses. Steven P. Millard is a statistical consultant and also Manager of Consulting Services for MathSoft, Inc. (Data Analysis Products Division.) He has applied statistical methods to projects ranging from quality control in bioassay to measuring water quality to automating home appraisal, and has taught courses in S-PLUS for over 10 years. He is the author of the book Environmental Statistics with S-PLUS (CRC Press) as well as the S-PLUS add-in module ENVIRONMENTALSTATS for S-PLUS. Andreas Krause is a statistical consultant in the pharmaceutical industry and works for Novartis Pharma AG. He has extensive experience in graphical and numerical data analysis as well as programming, has taught numerous classes with and on S-PLUS, and is an S_PLUS user from the early days on. He is also author of the book The Basics of S and S-PLUS (Springer).

Recenzje

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)

Spis treści

Statistics and the Drug Development Process, Bruce Rodda and Steven P. Millard * One-Factor Comparative Studies, Bill Pikounis * Analysis of Animal Carcinogenicity Data, Hongshik Ahn and Ralph L. Kodell * Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies, Wherly P. Hoffman, Michael A. Heathman, James Z. Chou, and Darrel L. Allen * Analysis of Pharmacokinetic Data, Ha Nguyen and Dhammika Amaratunga * Graphical Presentation of Single Patient Results, Jürgen Bock * Graphical Insight and Data Analysis for the 2, 2, 2, Crossover Design, Bill Pikounis, Tom Bradstreet, and Steven P. Millard * Design and Analysis of Phase I Trials in Clinical Oncology, Axel Benner, Lutz Elder, and Gernot Hartung * Patient Compliance and its Impact on Steady State Pharmacokinetics, Wenping Wang * Analysis of Analgesic Trials, Ene I. Ette, Peter Lockwood, Raymond Miller, and Jaap Mandema * Power and Sample Size Calculations, Jürgen Bock * Comparing Two Treatments in a Large Phase III Clinical Trial, Michaela Jahn * Analysis of Variance: A Comparison Between SAS and S-PLUS, Melvin Olson * Permutation Tests for Phase III Clinical Trials, Vance Berger and Anastasia Ivanova * Sample Size Reestimation, Wenping Wong and Andreas Krause * Meta-Analysis of Clinical Trials, Keith O'Rourke, Beverley Shea, and George A. Wells * Analysis of Health Economic Data, John R. Cook, George W. Carides, and Erik J. Dasbach * Evaluation of the Decimal Reduction Time of a Sterilization Process in Parmaceutical Production, Jeffrey Eisele, Mauro Gasparini, and Amy Racine * Acceptance Sampling Plans by Attributes, Harry Yang and David Carlin

O autorze

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.