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A randomized, cross-over trial of metoprolol succinate formulations to evaluate PK and PD end points for therapeutic equivalence.
Mosley, Scott A; Kim, Sarah; El Rouby, Nihal; Lingineni, Karthik; Esteban, Valvanera Vozmediano; Gong, Yan; Chen, Yiqing; Estores, David; Feng, Kairui; Kim, Hyewon; Kinjo, Minori; Langaee, Taimour; Li, Zhichuan; Schmidt, Siegfried O F; Johnson, Julie A; Frye, Reginald F; Fang, Lanyan Lucy; Zhao, Liang; Binkley, Philip F; Schmidt, Stephan; Cavallari, Larisa H.
Afiliação
  • Mosley SA; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Kim S; Department of Clinical Pharmacy, University of Southern California, Los Angeles, California, USA.
  • El Rouby N; Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, Florida, USA.
  • Lingineni K; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Esteban VV; Department of Pharmacy Practice and Administrative Sciences, University of Cincinnati, Cincinnati, Ohio, USA.
  • Gong Y; Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, Florida, USA.
  • Chen Y; Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, Florida, USA.
  • Estores D; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Feng K; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Kim H; Division of Gastroenterology, Hepatology, and Nutrition, College of Medicine, University of Florida, Gainesville, Florida, USA.
  • Kinjo M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Langaee T; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li Z; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schmidt SOF; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Johnson JA; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Frye RF; Department of Community Health and Family Medicine, College of Medicine, University of Florida, Gainesville, Florida, USA.
  • Fang LL; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Zhao L; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Binkley PF; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schmidt S; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Cavallari LH; Division of Cardiovascular Medicine, College of Medicine, The Ohio State University, Columbus, Ohio, USA.
Clin Transl Sci ; 15(7): 1764-1775, 2022 07.
Article em En | MEDLINE | ID: mdl-35488487

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Monitorização Ambulatorial da Pressão Arterial / Metoprolol Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans Idioma: En Revista: Clin Transl Sci Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Monitorização Ambulatorial da Pressão Arterial / Metoprolol Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans Idioma: En Revista: Clin Transl Sci Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos