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Book Categories |
Preface | ||
A Note About S-PLUS Versions | ||
Typographic Conventions | ||
Companion Web Site for This Book | ||
Information on S-PLUS | ||
Acknowledgments | ||
List of Contributors | ||
Pt. 1 | Introduction | 1 |
1 | Statistics and the Drug Development Process | 3 |
Pt. 2 | Basic Research and Preclinical Studies | 15 |
2 | One-Factor Comparative Studies | 17 |
Pt. 3 | Pre-Clinical Safety Assessment | 41 |
3 | Analysis of Animal Carcinogenicity Data | 43 |
4 | Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies | 75 |
Pt. 4 | Phase I Studies | 107 |
5 | Analysis of Pharmacokinetic Data | 109 |
6 | Graphical Presentation of Single Patient Results | 135 |
7 | Graphical Insight and Data Analysis for the 2,2,2 Crossover Design | 153 |
8 | Design and Analysis of Phase I Trials in Clinical Oncology | 189 |
9 | Patient Compliance and its Impact on Steady State Pharmacokinetics | 217 |
10 | Analysis of Analgesic Trials | 237 |
Pt. 5 | Phase II and Phase III Clinical Trials | 267 |
11 | Power and Sample Size Calculations | 269 |
12 | Comparing Two Treatments in a Large Phase III Clinical Trial | 299 |
13 | Analysis of Variance: A Comparison Between SAS and S-PLUS | 321 |
14 | Permutation Tests for Phase III Clinical Trials | 349 |
15 | Sample Size Reestimation | 375 |
16 | Meta-Analysis of Clinical Trials | 397 |
Pt. 6 | Phase IV Studies | 425 |
17 | Analysis of Health Economic Data | 427 |
Pt. 7 | Manufacturing and Production | 455 |
18 | Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production | 457 |
19 | Acceptance Sampling Plans by Attributes | 475 |
Index | 503 |
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