Statistical issues in drug development /

Bibliographic Details
Main Author:	Senn, Stephen
Format:	eBook
Language:	English
Published:	Chichester ; New York : John Wiley, ©1997.
Series:	Statistics in practice.
Subjects:	Drug development > Statistical methods. Clinical Trials Statistics > methods
Online Access:	Connect to the full text of this electronic book

Table of Contents:

Part I: 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, test of hypotheses and confidence intervals
The work of the pharmaceutical statistician
Part II: Statistical issues: debatable and controvertsial topics in drug development
Allocating treatments to patients in clinical trials
Baselines and covariate information
The measurement of treatment effects
Demographic sub-groups: representation and analysis
Multiplicity
Intention to treat
One-sided and two-sided tests
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, drug monitoring and pharmaco-epidemiology
Pharmaco-economics and portfolio management.