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Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study.
Kim, Sarah; Sharma, Vishnu D; Lingineni, Karthik; Farhan, Nashid; Fang, Lanyan; Zhao, Liang; Brown, Joshua D; Cristofoletti, Rodrigo; Vozmediano, Valvanera; Ait-Oudhia, Sihem; Lesko, Lawrence J; Trame, Mirjam N; Schmidt, Stephan.
Afiliación
  • Kim S; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Sharma VD; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Lingineni K; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Farhan N; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Brown JD; Center for Drug Evaluation & Safety, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.
  • Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Vozmediano V; Division of Therapeutic Equivalence, Brazilian Health Regulatory Agency (Anvisa), Brasilia, Brazil.
  • Ait-Oudhia S; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Lesko LJ; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Trame MN; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Schmidt S; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
J Clin Pharmacol ; 59(9): 1266-1274, 2019 09.
Article en En | MEDLINE | ID: mdl-31087554

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Preparaciones de Acción Retardada / Metoprolol Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Preparaciones de Acción Retardada / Metoprolol Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos