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.