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Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
Florian, Jeffry; Sun, Qin; Schrieber, Sarah J; White, Richard; Shubow, Sophie; Johnson-Williams, Bernadette E; Sheikhy, Morasa; Harrison, Nicholas R; Parker, Valerie J; Wang, Yow-Ming; Strauss, David G.
Afiliación
  • Florian J; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sun Q; Office of Clinical Pharmacology Immediate Office, 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.
  • White R; Booz Allen Hamilton, McLean, Virginia, USA.
  • Shubow S; Office of Clinical Pharmacology Immediate Office, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Johnson-Williams BE; Office of Clinical Pharmacology Immediate Office, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sheikhy M; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Harrison NR; Duke-Margolis Center for Health Policy, Duke University, Durham, North Carolina, USA.
  • Parker VJ; Duke-Margolis Center for Health Policy, Duke University, Durham, North Carolina, USA.
  • Wang YM; Office of Clinical Pharmacology Immediate Office, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Strauss DG; Division of Applied Regulatory Science, 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 ; 113(5): 1030-1035, 2023 05.
Article en En | MEDLINE | ID: mdl-36380593
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas / Biosimilares Farmacéuticos Tipo de estudio: Guideline Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas / Biosimilares Farmacéuticos Tipo de estudio: Guideline Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos