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
Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians 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 industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
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.