Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Otros Autores: Davis, Jonathan R.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, DC : National Academy Press, ©1999.
Colección:Compass series (Washington, D.C.)
Temas:
United States. > Food and Drug Administration.
Clinical trials > Quality control.
Clinical trials > Data processing > Congresses.
Decision making.
Quality control.
United States Food and Drug Administration
Clinical Trials > standards
Decision Making
Quality Control
Research Design
Études cliniques > Qualité > Contrôle.
Études cliniques > Informatique > Congrès.
Prise de décision.
Qualité > Contrôle.
decision making.
quality control.
MEDICAL > Drug Guides.
MEDICAL > Nursing > Pharmacology.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
Clinical trials > Data processing.
Andre fag (naturvidenskab og teknik) > Andre fag.
Electronic books.
Congress
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Executive summary
  • Introduction
  • Presubmission and submission
  • FDA regulatory review
  • Summary of issues
  • Directions for the future
  • Final comments
  • Appendices.

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