Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products : workshop summary /

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process i...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Caruso, Denise, 1956- (rapporteur.)
Autor Corporativo: Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Workshop)
Otros Autores: English, Rebecca A. (rapporteur.), Claiborne, Anne B. (rapporteur.)
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, [2014]
Temas:
Pharmaceutical policy > United States > Decision making > Congresses.
Drugs > Law and legislation > United States > Decision making > Congresses.
Drugs > Risk assessment > United States > Decision making > Congresses.
Drugs > Testing > Government policy > United States > Congresses.
Drugs > Testing > Law and legislation > United States > Congresses.
Drugs.
Risk assessment.
Communication.
Misinformation.
Pharmaceutical Preparations
Risk Assessment
Communication
Drug Industry > standards
Legislation, Drug
Médicaments > Politique gouvernementale > États-Unis > Prise de décision > Congrès.
Médicaments > Évaluation du risque > États-Unis > Prise de décision > Congrès.
Médicaments > Essais cliniques > Politique gouvernementale > États-Unis > Congrès.
Médicaments.
Évaluation du risque.
Information.
Mésinformation.
risk assessment.
BUSINESS & ECONOMICS > Infrastructure.
SOCIAL SCIENCE > General.
Risk assessment
Drugs
Drugs > Testing > Government policy
Drugs > Testing > Law and legislation
United States
Congress
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction
  • Identifying and characterizing uncertainty
  • The regulators' challenge
  • Basic methodologies and applications for understanding and evaluating uncertainty
  • Communicating uncertainty
  • Final reflections on ways to characterize and communicate uncertainty.

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