2. Edition - January 2008
97.90 Euro
2008. 524 Pages, Hardcover
- Practical Approach Book -
ISBN-10: 0-470-01877-1
ISBN-13: 978-0-470-01877-4 - John Wiley & Sons






Sample Chapter

Short description
Written by an experienced and respected statistician with vast in-depth knowledge of the pharmaceutical industry, Statistical Issues in Drug Development, Second Edition presents a unique compendium of issues affecting statistics as applied to drug development.

From the contents
Preface to the Second Edition.

Preface to the First Edition.

Acknowledgements.

1. Introduction.

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

2. A Brief and Superficial History of Statistics for Drug Developers.

3. Design and Interpretation of Clinical Trials as Seen by a Statistician.

4. Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals.

5. The Work of the Pharmaceutical Statistician.

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

6. Allocating Treatments to Patients in Clinical Trials.

7. Baselines and Covariate Information.

8. The Measurement of Treatment Effects.

9. Demographic Subgroups: Representation and Analysis.

10. Multiplicity.

11. Intention to Treat, Missing Data and Related Matters.

12. One-sided and Two-sided Tests and Other Issues to Do with Significance and P-values.

13. Determining the Sample Size.

14. Multicentre Trials.

15. Active Control Equivalence Studies.

16. Meta-Analysis.

17. Cross-over Trials.

18. n-of-1 Trials.

19. Sequential Tr4ials.

20. Dose-finding.

21. Concerning Pharmacokinetics and Pharmacodynamics.

22. Bioequivalence Studies.

23. Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology.

24. Pharmaco-economics and Portfolio Management.

25. Concerning Pharmacogenetics, Pharmacogenomics and Related Matters.

Glossary.

Index.