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A Spike-Control Approach that Evaluates High Resolution Mass Spectrometry-Based Sequence Variant Analytical Method Performance for Therapeutic Proteins.
Zhang, Jinhui; Shih, Mack; Yan, Haoheng; O'Connor, Thomas; Ji, Chengjie; Faustino, Patrick J.
Afiliación
  • Zhang J; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Jinhui.Zhang@fda.hhs.gov.
  • Shih M; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
  • Yan H; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
  • O'Connor T; Global Regulatory Affairs, Shanghai Henlius Biotech Inc., 9F, Innov Tower, 1801 Hongmei Road, Shanghai, China.
  • Ji C; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
  • Faustino PJ; NovaBioAssays, 52 Dragon Court, Woburn, MA, 01801, USA.
Pharm Res ; 40(6): 1425-1433, 2023 Jun.
Article en En | MEDLINE | ID: mdl-37127779
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Programas Informáticos / Anticuerpos Monoclonales Tipo de estudio: Qualitative_research Idioma: En Revista: Pharm Res Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
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: Programas Informáticos / Anticuerpos Monoclonales Tipo de estudio: Qualitative_research Idioma: En Revista: Pharm Res Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos