Applied Statistics in the Pharmaceutical Industry : With Case Studies Using S-Plus （2001. XVIII, 513 p. w. 131 ill. 24,5 cm）

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Applied Statistics in the Pharmaceutical Industry : With Case Studies Using S-Plus （2001. XVIII, 513 p. w. 131 ill. 24,5 cm）

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  • 製本 Hardcover:ハードカバー版／ページ数 505 p.
  • 商品コード 9780387988146

Full Description

The purpose of this book is to provide a general guide to statistical methods used in the pharmaceutical industry, and to illustrate how to use S-PLUS to implement these methods. Specifically, the goal is to: *Illustrate statistical applications in the pharmaceutical industry; *Illustrate how the statistical applications can be carried out using S-PLUS; *Illustrate why S-PLUS is a useful software package for carrying out these applications; *Discuss the results and implications of a particular application; The target audience for this book is very broad, including: *Graduate students in biostatistics; *Statisticians who are 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 indsutry that they may not be familiar with; *Statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

Contents

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.