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Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations.
Mercea, Peter V; Ossberger, Manfred; Wyrwich, Regina; Herburger, Matthias; Barge, Vishal; Aluri, Rajendra; Tosa, Valer.
Afiliação
  • Mercea PV; FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany.
  • Ossberger M; FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany.
  • Wyrwich R; FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany; regina.wyrwich@fabes-online.de.
  • Herburger M; FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany.
  • Barge V; Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc., 375 North Field Drive, Lake Forest, IL 60045.
  • Aluri R; Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc. SIPCOT Industrial Park, Sriperumbudur, 602117 Tamil Nadu, India; and.
  • Tosa V; National Institute for Research and Development of Isotopic and Molecular Technologies, Str. Donath 67-103, 400293 Cluj-Napoca, Romania.
PDA J Pharm Sci Technol ; 78(1): 33-44, 2024 Feb 20.
Article em En | MEDLINE | ID: mdl-37580130
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Polienos / Embalagem de Medicamentos Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: PDA J Pharm Sci Technol Ano de publicação: 2024 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Polienos / Embalagem de Medicamentos Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: PDA J Pharm Sci Technol Ano de publicação: 2024 Tipo de documento: Article