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Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
Liu, Xiaomei I; Dallmann, André; Wang, Yow-Ming; Green, Dionna J; Burnham, Janelle M; Chiang, Beatrice; Wu, Perry; Sheng, Mark; Lu, Kelley; van den Anker, John N; Burckart, Gilbert J.
Afiliación
  • Liu XI; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Dallmann A; Children's National Medical Center, Washington, DC, USA.
  • Wang YM; Pediatric Pharmacology and Pharmacometrics Research Center, University Children's Hospital Basel (UKBB), Switzerland.
  • Green DJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Burnham JM; Office of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, MD, USA.
  • Chiang B; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Wu P; School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
  • Sheng M; School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
  • Lu K; School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
  • van den Anker JN; College of Pharmacy, University of Texas, Austin, TX, USA.
  • Burckart GJ; Children's National Medical Center, Washington, DC, USA.
J Clin Pharmacol ; 59(8): 1130-1143, 2019 08.
Article en En | MEDLINE | ID: mdl-30865317
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Proteínas Recombinantes de Fusión / Receptores Fc / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Humans / Middle aged País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Proteínas Recombinantes de Fusión / Receptores Fc / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Humans / Middle aged País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido