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Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development.
Obianom, O N; Thway, Theingi M; Schrieber, S J; Okusanya, O O; Wang, Y M; Huang, S M; Zineh, I.
Afiliación
  • Obianom ON; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
  • Thway TM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. thway.theingi@gmail.com.
  • Schrieber SJ; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Okusanya OO; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
  • Wang YM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
  • Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
  • Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
AAPS J ; 21(6): 105, 2019 09 11.
Article en En | MEDLINE | ID: mdl-31512109
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Productos Biológicos / Descubrimiento de Drogas / Biosimilares Farmacéuticos / Desarrollo de Medicamentos Tipo de estudio: Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies País/Región como asunto: America do norte Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2019 Tipo del documento: Article
Texto completo
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XML
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Productos Biológicos / Descubrimiento de Drogas / Biosimilares Farmacéuticos / Desarrollo de Medicamentos Tipo de estudio: Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies País/Región como asunto: America do norte Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2019 Tipo del documento: Article