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Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective.
Fang, Lanyan; Uppoor, Ramana; Xu, Mingjiang; Sharan, Satish; Zhu, Hao; Tampal, Nilufer; Li, Bing; Zhang, Lei; Lionberger, Robert; Zhao, Liang.
Afiliação
  • Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Uppoor R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Xu M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sharan S; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tampal N; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li B; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 110(4): 880-887, 2021 10.
Article em En | MEDLINE | ID: mdl-33492710
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Disponibilidade Biológica / Equivalência Terapêutica / Área Sob a Curva / Controle de Medicamentos e Entorpecentes País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Disponibilidade Biológica / Equivalência Terapêutica / Área Sob a Curva / Controle de Medicamentos e Entorpecentes País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos