title: Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars.
authors: US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri, USA.
authors: Houman
authors: H
authors: Ghasriani
authors: Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Ontario, Canada.
authors: Derek J
authors: DJ
authors: Hodgson
authors: Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, Rockville, Maryland, USA.
authors: Robert G
authors: RG
authors: Brinson
authors: Medical Products Agency of Sweden, Uppsala, Sweden.
authors: Ian
authors: I
authors: McEwen
authors: US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri, USA.
authors: Lucinda F
authors: LF
authors: Buhse
authors: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biotechnology Products, Silver Spring, Maryland, USA.
authors: Steven
authors: S
authors: Kozlowski
authors: Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, Rockville, Maryland, USA.
authors: John P
authors: JP
authors: Marino
authors: Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Ontario, Canada.
authors: Yves
authors: Y
authors: Aubin
authors: US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri, USA.
authors: David A
authors: DA
authors: Keire
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000032:analysis / Q000737:chemistry / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D000069585:Filgrastim / Q000032:analysis / Q000737:chemistry / Q000592:standards; D019906:Nuclear Magnetic Resonance, Biomolecular / Q000379:methods*; D015203:Reproducibility of Results
chemical_list: D059451:Biosimilar Pharmaceuticals; D000069585:Filgrastim