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FDA's Approval of the First Biosimilar to Bevacizumab.
Casak, Sandra J; Lemery, Steven J; Chung, Jee; Fuchs, Chana; Schrieber, Sarah J; Chow, Edwin C Y; Yuan, Weishi; Rodriguez, Lisa; Gwise, Thomas; Rowzee, Anne; Lim, Sue; Keegan, Patricia; McKee, Amy E; Pazdur, Richard.
Afiliación
  • Casak SJ; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Sandra.casak@fda.hhs.gov.
  • Lemery SJ; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chung J; Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fuchs C; Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Schrieber SJ; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chow ECY; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yuan W; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rodriguez L; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gwise T; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rowzee A; Therapeutic Biologics and Biosimilar Staff, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lim S; Therapeutic Biologics and Biosimilar Staff, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Keegan P; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • McKee AE; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 24(18): 4365-4370, 2018 09 15.
Article en En | MEDLINE | ID: mdl-29743182
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Biosimilares Farmacéuticos / Bevacizumab Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article
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: Carcinoma de Pulmón de Células no Pequeñas / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Biosimilares Farmacéuticos / Bevacizumab Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article