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Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis.
Laurén, Anna; Braun, Manuela; Cazzin, Chiara; Colleti, Kelly; Cox, Chris; Dietz, Lisa; Emrich, Thomas; Geddes, Kristin; Herr, Kate; Iles, Tracy; Rogue, Alexandra; Verlinden, Yvan; Timmerman, Philip.
Afiliação
  • Laurén A; Novo Nordisk A/S, Non-clinical and Clinical Assay Sciences, Global Discovery and Development Sciences, Global Drug Discovery, Maaløv, 2760, Denmark.
  • Braun M; Bayer AG, DMPK Project Management, Research and Development, Pharmaceuticals, Berlin, 13342, Germany.
  • Cazzin C; Aptuit Srl, an Evotec Company, ADMET & Bioanalytical Sciences Dept., Campus Levi-Montalcini, Verona, 37135, Italy.
  • Colleti 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 and Co., Inc., PCD-BA Regulated Immunogenicity, Rahway, NJ, 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; Department of Biomarker, Charles River Laboratories, Evreux, 27000, France.
  • Verlinden Y; Janssen BioTherapeutics, JBIO Beerse Bioanalysis Laboratory, Beerse, 2340, Belgium.
  • Timmerman P; European Bioanalysis Forum, Brussels, 1000, Belgium.
Bioanalysis ; 14(16): 1085-1093, 2022 Aug.
Article em En | MEDLINE | ID: mdl-36125042
ABSTRACT
In this manuscript, the European Bioanalysis Forum reports back on their discussions on practical and scientific considerations related to bioanalytical applications of quantitative polymerase chain reaction. This publication follows an earlier publication in which the European Bioanalysis Forum recommends to consider principles of context of use when defining assay acceptance criteria for method validation criteria and sample analysis.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bioensaio / Laboratórios Idioma: En Ano de publicação: 2022 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: Bioensaio / Laboratórios Idioma: En Ano de publicação: 2022 Tipo de documento: Article