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Statistics book from C.H.I.P.S.

Statistical Issues in Drug Development
Second edition
by Stephen Senn

Statistical Issues in Drug Development, 2nd edition presents an essential and thought stimulating guide to the statistical issues and controversies involved in drug development.

Features:

  • Comprehensive coverage of the design and interpretation of clinical trials.
  • Expanded sections on missing data, equivalence, meta-analysis and dose finding.
  • An examination of both Bayesian and frequentist methods.
  • A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics.
  • Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials

Contents

  1. Introduction

Part 1: Four Views of Statistics in Drug Development: Historical, Methodological, Technical and Professional

  1. A Brief and Superficial History of Statistics for Drug Developers
  2. Design and Interpretation of Clinical Trials as Seen by a Statistician
  3. Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
  4. The Work of the Pharmaceutical Statistician

Part 2: Statistical Issues: Debatable and Controversial Topics in Drug Development

  1. Allocating Treatments to Patients in Clinical Trials
  2. Baselines and Covariate Information
  3. The Measurement of Treatment Effects
  4. Demographic Subgroups: Representation and Analysis
  5. Multiplicity
  6. Intention to Treat, Missing Data and Related Matters
  7. One-sided and Two-sided Tests and Other Issues to Do with Significance and P-values
  8. Determining the Sample Size
  9. Multicentre Trials
  10. Active Control Equivalence Studies
  11. Meta-Analysis
  12. Cross-over Trials
  13. n-of-1 Trials
  14. Sequential Tr4ials
  15. Dose-finding
  16. Concerning Pharmacokinetics and Pharmacodynamics
  17. Bioequivalence Studies
  18. Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
  19. Pharmaco-economics and Portfolio Management
  20. Concerning Pharmacogenetics, Pharmacogenomics and Related Matters

Index

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Statistical Issues in Drug Development
Second edition
by Stephen Senn

2008 524 pages $129.00 + shipping
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