Applied Statistics in the Pharmaceutical Industry: With Case Studies Using S-Plus

Front Matter....Pages i-xviii
Front Matter....Pages 1-1
Statistics and the Drug Development Process....Pages 3-14
Front Matter....Pages 15-15
One-Factor Comparative Studies....Pages 17-40
Front Matter....Pages 41-41
Analysis of Animal Carcinogenicity Data....Pages 43-73
Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies....Pages 75-106
Front Matter....Pages 107-107
Analysis of Pharmacokinetic Data....Pages 109-133
Graphical Presentation of Single Patient Results....Pages 135-151
Graphical Insight and Data Analysis for the 2,2,2 Crossover Design....Pages 153-188
Design and Analysis of Phase I Trials in Clinical Oncology....Pages 189-216
Patient Compliance and its Impact on Steady State Pharmacokinetics....Pages 217-236
Analysis of Analgesic Trials....Pages 237-266
Front Matter....Pages 267-267
Power and Sample Size Calculations....Pages 269-297
Comparing Two Treatments in a Large Phase III Clinical Trial....Pages 299-320
Analysis of Variance: A Comparison Between SAS and S-PLUS....Pages 321-347
Permutation Tests for Phase III Clinical Trials....Pages 349-374
Sample Size Reestimation....Pages 375-396
Meta-Analysis of Clinical Trials....Pages 397-424
Front Matter....Pages 425-425
Analysis of Health Economic Data....Pages 427-454
Front Matter....Pages 455-455
Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production....Pages 457-474
Acceptance Sampling Plans by Attributes....Pages 475-502
Back Matter....Pages 503-515