Statistical Issues in Drug Develop 2e

2. Auflage 2008
ISBN: 978-0-470-01877-4
Verlag: John Wiley & Sons

Buch, Englisch, 524 Seiten, HC gerader Rücken kaschiert, Format (B × H): 175 mm x 250 mm, Gewicht: 1086 g

Reihe: Statistics in Practice

Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.

Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development.

This highly readable second edition has been updated to include:

* 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.

It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

Autoren/Hrsg.

Senn

Senn, Stephen S.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Mathematik | Informatik Mathematik Stochastik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Naturwissenschaften Biowissenschaften Angewandte Biologie Biomathematik

Inhaltsverzeichnis

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.