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.

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