An introduction to statistics in early phase trials /

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* An overview of the most common types of trial undertaken in early clinical development. * A simple and concise overview of the different methodologies and the impact of new technologies, clinical and statistical, on clinical development. * Describes how information at the end of early phase develo...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Julious, Steven A.
Otros Autores: Machin, David, 1939-, Tan, Say Beng
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Chichester, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Temas:
Drugs > Testing > Statistical methods.
Clinical trials > Statistical methods.
Clinical Trials, Phase I as Topic > methods
Biometry > methods
Clinical Trials, Phase II as Topic > methods
Models, Statistical
Statistics as Topic > methods
Médicaments > Essais cliniques > Méthodes statistiques.
Études cliniques > Méthodes statistiques.
MEDICAL > Drug Guides.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
MEDICAL > Nursing > Pharmacology.
Clinical trials > Statistical methods
Drugs > Testing > Statistical methods
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Early phase trials
  • Introduction to pharmacokinetics
  • Sample size calculations for clinical trials
  • Crossover trial basics
  • Multi-period crossover trials
  • First time into man
  • Bayesian and frequentist methods
  • First-time-into-new-population studies
  • Bioequivalence studies
  • Other phase I trials
  • Phase II trials : general issues
  • Dose-response studies
  • Phase II trials with toxic therapies
  • Interpreting and applying early phase trial results
  • Go/no-go criteria.

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