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Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018.
Steinbronn, Claire; Yang, Xinning; Yu, Jingjing; Dimova, Hristina; Huang, Shiew-Mei; Ragueneau-Majlessi, Isabelle; Isoherranen, Nina.
Afiliación
  • Steinbronn C; Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.
  • Yang X; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yu J; Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.
  • Dimova H; UW Drug Interaction Solutions, University of Washington, Seattle, Washington, USA.
  • Huang SM; Center for Tobacco Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ragueneau-Majlessi I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Isoherranen N; Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.
Clin Pharmacol Ther ; 110(2): 452-463, 2021 08.
Article en En | MEDLINE | ID: mdl-33835478

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Interacciones Farmacológicas Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Interacciones Farmacológicas Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos