Statistical issues in drug development

Main Author: Senn, Stephen.
Corporate Author: ebrary, Inc.
Format: Book
Language:English
Published: Chichester, England ; Hoboken, NJ : John Wiley & Sons, c2007.
Edition:2nd ed.
Series:Statistics in practice
Subjects:
Online Access:http://site.ebrary.com/lib/ucy/Doc?id=10232744
Table of Contents:
  • The measurement of treatment effects
  • Demographic subgroups : 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
  • Multicentre 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.