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International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.
Prior, Sandra; Hufton, Simon E; Fox, Bernard; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian.
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  • Prior S; a Molecular Immunology Section, Biotherapeutics Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
  • Hufton SE; a Molecular Immunology Section, Biotherapeutics Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
  • Fox B; a Molecular Immunology Section, Biotherapeutics Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
  • Dougall T; b Technology Development and Infrastructure Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
  • Rigsby P; b Technology Development and Infrastructure Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
  • Bristow A; b Technology Development and Infrastructure Division, National Institute for Biological Standards and Control, South Mimms , Potters Bar , Hertfordshire , United Kingdom.
MAbs ; 10(1): 129-142, 2018 01.
Article en En | MEDLINE | ID: mdl-28985159
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Control de Calidad / Bioensayo / Tecnología Farmacéutica / Biosimilares Farmacéuticos / Rituximab / Desarrollo de Medicamentos / Factores Inmunológicos Tipo de estudio: Clinical_trials / Evaluation_studies / Guideline / Prognostic_studies Idioma: En Revista: MAbs Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Control de Calidad / Bioensayo / Tecnología Farmacéutica / Biosimilares Farmacéuticos / Rituximab / Desarrollo de Medicamentos / Factores Inmunológicos Tipo de estudio: Clinical_trials / Evaluation_studies / Guideline / Prognostic_studies Idioma: En Revista: MAbs Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Reino Unido