Statistical thinking for non-statisticians in drug regulation /

Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device in...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Kay, R. (Richard), 1949- (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Chichester, West Sussex, UK ; Hoboken, NJ, USA : John Wiley & Sons Inc., 2015.
Edición:Second edition.
Temas:
Pharmaceutical industry > Statistical methods.
Drug approval > Statistical methods.
Drugs > Testing > Statistical methods.
Clinical trials > Statistical methods.
Statistics.
Pharmaceutical industry.
Drug Approval
Clinical Trials as Topic > methods
Statistics as Topic
Drug Industry
Industrie pharmaceutique > Méthodes statistiques.
Médicaments > Autorisation de mise sur le marché > Méthodes statistiques.
Médicaments > Essais cliniques > Méthodes statistiques.
Études cliniques > Méthodes statistiques.
Statistiques.
Industrie pharmaceutique.
Statistique.
statistics.
MEDICAL > Pharmacology.
Statistics
Pharmaceutical industry
Clinical trials > Statistical methods
Drugs > Testing > Statistical methods
Pharmaceutical industry > Statistical methods
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Basic ideas in clinical trial design
  • Sampling and inferential statistics
  • Confidence intervals and p-values
  • Tests for simple treatment comparisons
  • Adjusting the analysis
  • Regression and analysis of covariance
  • Intention-to-treat and analysis sets
  • Power and sample size
  • Statistical significance and clinical importance
  • Multiple testing
  • Non-parametric and related methods
  • Equivalence and non-inferiority
  • The analysis of survival data
  • Interim analysis and data monitoring committees
  • Bayesian statistics
  • Adaptive designs
  • Observational studies
  • Meta-analysis
  • Methods for the safety analysis and safety monitoring
  • Diagnosis
  • The role of statistics and statisticians.

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