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Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation.
Maro, Judith C; Nguyen, Michael D; Kolonoski, Joy; Schoeplein, Ryan; Huang, Ting-Ying; Dutcher, Sarah K; Dal Pan, Gerald J; Ball, Robert.
Afiliação
  • Maro JC; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA.
  • Nguyen MD; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kolonoski J; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA.
  • Schoeplein R; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA.
  • Huang TY; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA.
  • Dutcher SK; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Dal Pan GJ; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ball R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 114(4): 815-824, 2023 10.
Article em En | MEDLINE | ID: mdl-37391385
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Alimentos Tipo de estudo: Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Alimentos Tipo de estudo: Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2023 Tipo de documento: Article