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Comparability Considerations and Challenges for Expedited Development Programs for Biological Products.
Schrieber, Sarah J; Putnam, Wendy S; Chow, Edwin Chiu Yuen; Cieslak, Jacek; Zhuang, Yanli; Martin, Steven W; Hanson, Paul; Maggio, Frank; Rosado, Leslie A Rivera.
Afiliación
  • Schrieber SJ; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20903, USA. sarah.schrieber@fda.hhs.gov.
  • Putnam WS; Department of Clinical Pharmacology, Genentech, Inc., South San Francisco, CA, USA.
  • Chow ECY; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Cieslak J; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Zhuang Y; Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, LLC, Spring House, PA, USA.
  • Martin SW; Pharmacometrics Group, Department of Clinical Pharmacology, Global Product Development, Pfizer Inc., Cambridge, MA, USA.
  • Hanson P; Global Manufacturing and Supply, Takeda Pharmaceuticals International Co, Cambridge, MA, USA.
  • Maggio F; Product Quality, Amgen Inc, Thousand Oaks, CA, USA.
  • Rosado LAR; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Drugs R D ; 20(4): 301-306, 2020 Dec.
Article en En | MEDLINE | ID: mdl-32914381
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Desarrollo de Medicamentos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Drugs R D Asunto de la revista: TERAPIA POR MEDICAMENTOS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Desarrollo de Medicamentos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Drugs R D Asunto de la revista: TERAPIA POR MEDICAMENTOS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda