Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary

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 pro...

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Detalles Bibliográficos
Autores Corporativos: Board on Health Sciences Policy (-), Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, Institute of Medicine (U.S.), Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Workshop)
Otros Autores: Caruso, Denise, author (author), English, Rebecca A., author, Claiborne, Anne B., author
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, District of Columbia : The National Academies Press 2014.
Edición:1st ed
Materias:
Risk assessment > Congresses.
Communication > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622069906719
Tabla de Contenidos:
  • ""Front Matter""; ""Reviewers""; ""Contents""; ""Boxes, Figures, and Table""; ""Acronyms""; ""1 Introduction""; ""2 Identifying and Characterizing Uncertainty""; ""3 The Regulators Challenge""; ""4 Basic Methodologies and Applications for Understanding and Evaluating Uncertainty""; ""5 Communicating Uncertainty""; ""6 Final Reflections on Ways to Characterize and Communicate Uncertainty""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: FDA Case Studies""; ""Appendix C: Bibliography""; ""Appendix D: Participant Biographies""

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