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Factors Governing the Precision of Subvisible Particle Measurement Methods - A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe.
Ríos Quiroz, Anacelia; Lamerz, Jens; Da Cunha, Thierry; Boillon, Adeline; Adler, Michael; Finkler, Christof; Huwyler, Joerg; Schmidt, Roland; Mahler, Hanns-Christian; Koulov, Atanas V.
  • Ríos Quiroz A; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Lamerz J; Analytical Development & Quality Control, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Da Cunha T; Department of Pharmaceutical Sciences, Division of Pharmaceutical Technology, University of Basel, 4056, Basel, Switzerland.
  • Boillon A; Pharma Development, Biometry, NonClinical Biostatistics, F. Hoffmann - La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Adler M; Analytical Development & Quality Control, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Finkler C; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Huwyler J; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Schmidt R; Analytical Development & Quality Control, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Mahler HC; Department of Pharmaceutical Sciences, Division of Pharmaceutical Technology, University of Basel, 4056, Basel, Switzerland.
  • Koulov AV; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics Europe, F. Hoffman-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
Pharm Res ; 33(2): 450-61, 2016 Feb.
Article en En | MEDLINE | ID: mdl-26474763
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proteínas / Técnicas de Química Analítica Tipo de estudio: Guideline / Prognostic_studies Idioma: En Año: 2016 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proteínas / Técnicas de Química Analítica Tipo de estudio: Guideline / Prognostic_studies Idioma: En Año: 2016 Tipo del documento: Article