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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.
Li, Junyi; Florian, Jeffry; Campbell, Elizabeth; Schrieber, Sarah J; Bai, Jane P F; Weaver, James L; Hyland, Paula L; Thway, Theingi M; Matta, Murali K; Lankapalli, Rachana H; Narayanasamy, Suresh; Dancy, Jimena; Zusterzeel, Robbert; Tyson, Jessica Y; Prentice, Kristin W; Jackson, Kathryn C; Patel, Vikram; Rouse, Rodney L; Wang, Yow-Ming C; Strauss, David G.
Afiliación
  • Li J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Florian J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Campbell E; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schrieber SJ; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bai JPF; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Weaver JL; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Hyland PL; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Thway TM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Matta MK; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lankapalli RH; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Narayanasamy S; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Dancy J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zusterzeel R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tyson JY; Booz Allen Hamilton, Mclean, Virginia, USA.
  • Prentice KW; Booz Allen Hamilton, Mclean, Virginia, USA.
  • Jackson KC; Booz Allen Hamilton, Mclean, Virginia, USA.
  • Patel V; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Rouse RL; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang YC; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Strauss DG; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 107(1): 40-42, 2020 01.
Article en En | MEDLINE | ID: mdl-31667825
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Biomarcadores Farmacológicos / Biosimilares Farmacéuticos Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Biomarcadores Farmacológicos / Biosimilares Farmacéuticos Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos