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Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools.
Sobel, Rachel E; Bate, Andrew; Marshall, James; Haynes, Kevin; Selvam, Nandini; Nair, Vinit; Daniel, Gregory; Brown, Jeffrey S; Reynolds, Robert F.
  • Sobel RE; Epidemiology/Worldwide Research and Development, Pfizer Inc, New York, NY, USA.
  • Bate A; Epidemiology/Worldwide Research and Development, Pfizer Inc, New York, NY, USA.
  • Marshall J; Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Haynes K; HealthCore, Inc, Wilmington, DE, USA.
  • Selvam N; HealthCore, Inc, Wilmington, DE, USA.
  • Nair V; Humana Inc, Louisville, KY, USA.
  • Daniel G; Duke-Robert J. Margolis, MD Center for Health Policy, Duke University, Washington, DC, USA.
  • Brown JS; Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Reynolds RF; Epidemiology/Worldwide Research and Development, Pfizer Inc, New York, NY, USA.
Pharmacoepidemiol Drug Saf ; 27(3): 332-339, 2018 03.
Article en En | MEDLINE | ID: mdl-29392851

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / United States Food and Drug Administration / Etiquetado de Medicamentos / Inhibidores de la Bomba de Protones Tipo de estudio: Diagnostic_studies / Etiology_studies / Evaluation_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged País como asunto: America do norte Idioma: En Año: 2018 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / United States Food and Drug Administration / Etiquetado de Medicamentos / Inhibidores de la Bomba de Protones Tipo de estudio: Diagnostic_studies / Etiology_studies / Evaluation_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged País como asunto: America do norte Idioma: En Año: 2018 Tipo del documento: Article