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.

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.