Stephen S. Senn

Statistical Issues in Drug Development

• Gebundenes Buch

Produktbeschreibung

Statistische Aspekte der Wirkstoffentwicklung erläutert der Autor hier für Nicht-Fachleute, um ihnen die Kommunikation mit Statistikern bei der Planung, Analyse und Interpretation klinischer Versuche zu erleichtern - besonders nützlich für Mediziner und Pharmakologen, die bisher keine tiefergehenden Vorkenntnisse in statistischer Methodik erwerben konnten. Ein auf ihrem Gebiet konkurrenzlose Publikation! There are many books on medical statistics that explain to the physician how to calculate various common statistics and how to perform various tests. Many of them present a simplified and distorted view of statistics, which gives no impression of the philosophical difficulties that the science has to confront.

Produktdetails

• Statistics in Practice
• Verlag: Wiley & Sons
• 2. Aufl.
• Seitenzahl: 512
• Erscheinungstermin: Januar 2008
• Englisch
• Gewicht: 1046g
• ISBN-13: 9780470018774
• ISBN-10: 0470018771
• Artikelnr.: 23046078

Inhaltsangabe

- Preface to the Second Edition

- Preface to the First Edition

- Introduction

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

- A Brief and Superficial History of Statistics for Drug Developers

- Design and Interpretation of Clinical Trials as Seen by a Statistician

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

- The Work of the Pharmaceutical Statistician

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

- Allocating Treatments to Patients in Clinical Trials

- Baselines and Covariate Information

- The Measurement of Treatment Effects

- Demographic Sub-group: Representation and Analysis

- Multiplicity

- Intention to treat, Missing Data and Related Matters

- One Sided and two Sided Tests and Other Issues to do with Significance and P-values

- Determining the Sample Size

- Multi-Centre Trials

- Active Control Equivalence Studies

- Meta-Analysis

- Cross-over Trials

- N-of-1 Trials

- Sequential Trials

- Dose-finding

- Concerning Pharmacokinetics and Pharmacodynamics

- Bioequivalence Studies

- Safety Data, Harms, Drug-Monitoring and Pharmaco-Epidemiology

- Pharmaco-Economics and Portfolio Management

- Concerning Pharmacogenetics, Pharmacogenomics and Related Matters

- Glossary

- Index