Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefi...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Leong, James (Autor), Salek, Sam (Autor), Walker, Stuart (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Adis, 2015.
Edición:1st ed. 2015.
Temas:
Pharmacovigilance.
Quality of life.
Drug Safety and Pharmacovigilance.
Quality of Life Research.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Prologue
  • Preface
  • Overview
  • Approaches to utilising decision-making framework
  • Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities
  • Development of a universal benefit-risk framework and template
  • Implementation of the benefit-risk assessment template by mature agencies
  • Implementation of the benefit- risk summary template by a maturing agency: A case study
  • Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada
  • Conclusions and future directions
  • References.

Ejemplares similares