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Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.
Pignatti, F; Ashby, D; Brass, E P; Eichler, H-G; Frey, P; Hillege, H L; Hori, A; Levitan, B; Liberti, L; Löfstedt, R E; McAuslane, N; Micaleff, A; Noel, R A; Postmus, D; Renn, O; Sabourin, B J; Salmonson, T; Walker, S.
Afiliación
  • Pignatti F; The European Medicines Agency, London, United Kingdom.
  • Ashby D; School of Public Health, Imperial College London, London, United Kingdom.
  • Brass EP; Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
  • Eichler HG; The European Medicines Agency, London, United Kingdom.
  • Frey P; Food and Drug Administration, Silver Spring, Maryland, USA.
  • Hillege HL; University of Groningen, Groningen, The Netherlands.
  • Hori A; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Levitan B; Janssen Pharmaceutical Research and Development, Titusville, New Jersey, USA.
  • Liberti L; Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
  • Löfstedt RE; Risk Research Group, Centre for Environmental Strategy, University of Surrey, Guildford, United Kingdom.
  • McAuslane N; Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
  • Micaleff A; Merck Serono, Geneva, Switzerland.
  • Noel RA; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Postmus D; The European Medicines Agency, London, United Kingdom.
  • Renn O; Institut für Sozialwissenschaften, Universität Stuttgart, Stuttgart, Germany.
  • Sabourin BJ; Health Canada, Ottawa, Ontario, Canada.
  • Salmonson T; Läkemedelsverket, Uppsala, Sweden.
  • Walker S; Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
Clin Pharmacol Ther ; 98(5): 522-33, 2015 Nov.
Article en En | MEDLINE | ID: mdl-26261064
ABSTRACT
Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Comunicación / Medición de Riesgo / Agencias Gubernamentales Tipo de estudio: Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: Clin Pharmacol Ther Año: 2015 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Comunicación / Medición de Riesgo / Agencias Gubernamentales Tipo de estudio: Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: Clin Pharmacol Ther Año: 2015 Tipo del documento: Article País de afiliación: Reino Unido