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

Applied Statistics in the Pharmaceutical Industry: With Case Studies Using S-PLUS
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  • Applied Statistics in the Pharmaceutical Industry: With Case Studies Using S-PLUS
  • Written by author Steven P. Millard
  • Published by Springer-Verlag New York, LLC, June 2001
  • Each year hundreds of new drugs are approved for the marketplace. The approval of a single new drug is the result of years of screening tens of thousands of compounds, performing pre-clinical research on their effects, and designing, implementing, and ana
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Authors

Preface
A Note About S-PLUS Versions
Typographic Conventions
Companion Web Site for This Book
Information on S-PLUS
Acknowledgments
List of Contributors
Pt. 1Introduction1
1Statistics and the Drug Development Process3
Pt. 2Basic Research and Preclinical Studies15
2One-Factor Comparative Studies17
Pt. 3Pre-Clinical Safety Assessment41
3Analysis of Animal Carcinogenicity Data43
4Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies75
Pt. 4Phase I Studies107
5Analysis of Pharmacokinetic Data109
6Graphical Presentation of Single Patient Results135
7Graphical Insight and Data Analysis for the 2,2,2 Crossover Design153
8Design and Analysis of Phase I Trials in Clinical Oncology189
9Patient Compliance and its Impact on Steady State Pharmacokinetics217
10Analysis of Analgesic Trials237
Pt. 5Phase II and Phase III Clinical Trials267
11Power and Sample Size Calculations269
12Comparing Two Treatments in a Large Phase III Clinical Trial299
13Analysis of Variance: A Comparison Between SAS and S-PLUS321
14Permutation Tests for Phase III Clinical Trials349
15Sample Size Reestimation375
16Meta-Analysis of Clinical Trials397
Pt. 6Phase IV Studies425
17Analysis of Health Economic Data427
Pt. 7Manufacturing and Production455
18Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production457
19Acceptance Sampling Plans by Attributes475
Index503


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