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TitleApplied Statistics in the Pharmaceutical Industry [electronic resource] : With Case Studies Using S-Plus / edited by Steven P. Millard, Andreas Krause
ImprintNew York, NY : Springer New York : Imprint: Springer, 2001
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Descript XVIII, 514 p. online resource


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


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

Statistics Bioinformatics Computational biology Statistics Statistics for Life Sciences Medicine Health Sciences Computer Appl. in Life Sciences


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