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Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum.
Laurén, Anna; Braun, Manuela; Byrne, Paul; Cazzin, Chiara; Colletti, Kelly; Cox, Chris; Dietz, Lisa; Emrich, Thomas; Geddes, Kristin; Herr, Kate; Iles, Tracy; Rogue, Alexandra; Verlinden, Yvan; Timmerman, Philip.
Afiliación
  • Laurén A; Novo Nordisk A/S, Non-Clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Global Drug Discovery, Maløv, DK-2760, Denmark.
  • Braun M; Bayer AG, DMPK Project Management, Research & Development, Pharmaceuticals, Berlin, 13342, Germany.
  • Byrne P; Labcorp Drug Development, Biopharmaceutical CMC Solutions, Harrogate, HG3 1PY, UK.
  • Cazzin C; Aptuit Srl, an Evotec Company, ADMET & Bioanalytical Sciences Dept., Campus Levi-Montalcini, Verona, 37135, Italy.
  • Colletti K; Charles River Laboratories, Laboratory Sciences, Reno, NV 89511, USA.
  • Cox C; PsiOxus Therapeutics, 4-10 The Quadrant, Abingdon, Oxfordshire, OX14 3YS, UK.
  • Dietz L; Bayer AG, DMPK Bioanalytics, Research & Development, Pharmaceuticals, Wuppertal, 42096, Germany.
  • Emrich T; F Hoffmann La Roche Pharma Research & Early Development, Pharmaceutical Sciences, Large Molecule Bioanalytical Sciences, Roche Innovation Center Munich, Penzberg, 82377, Germany.
  • Geddes K; Merck & Co, PPDM Regulated Immunogenicity, Kenilworth, NJ 07033, USA.
  • Herr K; Janssen BioTherapeutics, Janssen Research & Development LLC., Spring House, PA 19477, USA.
  • Iles T; Labcorp Drug Development, Biopharmaceutical CMC Solutions, Harrogate, HG3 1PY, UK.
  • Rogue A; Charles River Laboratories, Biomarker department, Evreux, 27000, France.
  • Verlinden Y; Janssen BioTherapeutics, JBIO Beerse Bioanalysis Laboratory, Beerse, 2340, Belgium.
  • Timmerman P; European Bioanalysis Forum, Brussels, 1000, Belgium.
Bioanalysis ; 13(23): 1723-1729, 2021 Dec.
Article en En | MEDLINE | ID: mdl-34708666
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bioensayo / Reacción en Cadena de la Polimerasa Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Bioanalysis Año: 2021 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bioensayo / Reacción en Cadena de la Polimerasa Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Bioanalysis Año: 2021 Tipo del documento: Article