Statistical issues in drug development

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Bibliografski detalji
Glavni autor: Senn, Stephen
Autor kompanije: ebrary, Inc
Format: Elektronički e-knjiga
Jezik:engleski
Izdano: Chichester, England ; Hoboken, NJ : John Wiley & Sons, c2007.
Izdanje:2nd ed.
Serija:Statistics in practice.
Teme:
Online pristup:An electronic book accessible through the World Wide Web; click to view
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Sadržaj:
  • 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
  • Allocating treatments to patients in clinical trials
  • Baselines and covariate information
  • 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.