Applied Statistics in the Pharmaceutical Industry

1: Introduction.- 1. Statistics and the Drug Development Process.- 2: Basic Research and Preclinical Studies.- 2. One-Factor Comparative Studies.- 3: Pre-Clinical Safety Assessment.- 3. Analysis of Animal Carcinogenicity Data.- 4. Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies.- 4: Phase I Studies.- 5. Analysis of Pharmacokinetic Data.- 6. Graphical Presentation of Single Patient Results.- 7. Graphical Insight and Data Analysis for the 2,2,2 Crossover Design.- 8. Design and Analysis of Phase I Trials in Clinical Oncology.- 9. Patient Compliance and its Impact on Steady State Pharmacokinetics.- 10. Analysis of Analgesic Trials.- 5: Phase II and Phase III Clinical Trials.- 11. Power and Sample Size Calculations.- 12. Comparing Two Treatments in a Large Phase III Clinical Trial.- 13. Analysis of Variance: A Comparison Between SAS and S-PLUS.- 14. Permutation Tests for Phase III Clinical Trials.- 15. Sample Size Reestimation.- 16. Meta-Analysis of Clinical Trials.- 6: Phase IV Studies.- 17. Analysis of Health Economic Data.- 7: Manufacturing and Production.- 18. Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production.- 19. Acceptance Sampling Plans by Attributes.

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.

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)