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Modern analytics for synthetically derived complex drug substances: NMR, AFFF-MALS, and MS tests for glatiramer acetate.
Rogstad, Sarah; Pang, Eric; Sommers, Cynthia; Hu, Meng; Jiang, Xiaohui; Keire, David A; Boyne, Michael T.
Afiliación
  • Rogstad S; Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA.
  • Pang E; Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA.
  • Sommers C; Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA.
  • Hu M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.
  • Jiang X; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.
  • Keire DA; Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA. david.keire@fda.hhs.gov.
  • Boyne MT; Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA.
Anal Bioanal Chem ; 407(29): 8647-59, 2015 Nov.
Article en En | MEDLINE | ID: mdl-26458562
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Acetato de Glatiramer / Inmunosupresores Idioma: En Revista: Anal Bioanal Chem Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Acetato de Glatiramer / Inmunosupresores Idioma: En Revista: Anal Bioanal Chem Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos