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Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations.
Kim, Hyewon; Fang, Lanyan; Yu, Jingyu; Meng, Zhaoyu; Trame, Mirjam N; Schmidt, Stephan; Lesko, Lawrence J; Zhao, Liang.
Afiliação
  • Kim H; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 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.
  • Yu J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Meng Z; 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.
  • Lesko LJ; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, 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.
J Clin Pharmacol ; 59(8): 1061-1069, 2019 08.
Article em En | MEDLINE | ID: mdl-30716169
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fenitoína / Modelos Biológicos / Anticonvulsivantes Tipo de estudo: Guideline Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fenitoína / Modelos Biológicos / Anticonvulsivantes Tipo de estudo: Guideline Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos