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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

Autor: Kholmanskikh O; Belgium FAMHP, Brussels, Belgium., Wang YM; US FDA, Silver Spring, MD, USA., Hersey S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Wadhwa M; UK MHRA, London, UK., Block K; Genentech, South San Francisco, CA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Szapacs M; Abbvie, Philadelphia, PA, USA., Weiner R; Takeda, Cambridge, MA, USA., Awwad K; Abbvie, Ludwigshafen, Germany., Dessy F; GlaxoSmithKline, Rixensart, Belgium.; Takeda, Cambridge, MA, USA., Downing S; Takeda, Cambridge, MA, USA., Du X; US FDA, Silver Spring, MD, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Harris S; HilleVax, Cambridge, MA, USA., Hou V; Moderna, Cambridge, MA, USA., Jones J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Kar S; WRIB, Toronto, ON, Canada., Kinhikar A; Novartis, Cambridge, MA, USA., Li M; Stoke, Cambridge, MA, USA., Mathews J; Ionis, Carlsbad, CA, USA., Meissen J; AstraZeneca, South San Francisco, CA, USA., Sumner GO; Regeneron, Tarrytown, NY, USA., Pan L; Takeda, Cambridge, MA, USA., Sanderink G; Sanofi Pasteur, Swiftwater, PA, USA., Scully I; Pfizer, Pearl River, NY, USA., Stanta J; Celerion, Stevenage, UK., Tanaka Y; Japan MHLW, Tokyo, Japan., Vauleon S; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Wagner L; US FDA, Silver Spring, MD, USA., Wang K; GlaxoSmithKline, Collegeville, PA, USA., Zhu L; Moderna, Cambridge, MA, USA., Eck S; AstraZeneca, Gaithersburg, MD, USA., Lin YD; Takeda, Cambridge, MA, USA., Azadeh M; Ultragenyx, Cambridge, MA, USA., Decman V; GlaxoSmithKline, Collegeville, PA, USA., Diebold S; UK MHRA, London, UK., Du X; US FDA, Silver Spring, MD, USA., Goihberg P; Pfizer, Andover, MA, USA., Alcaide EG; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Gonneau C; Labcorp, Meyrin, Switzerland., Hedrick MN; Bristol Myers Squibb, Lawrenceville, NJ, USA., Hopkins G; 2seventy Bio, Cambridge, MA, USA., Kar S; WRIB, Toronto, ON, Canada., Loschko J; Pfizer, Pearl River, NY, USA., McCausland M; Q2 Solutions, Atlanta. GA, USA., Mendez L; Merck, Kenilworth, NJ, USA., Sehra S; Incyte, Wilmington, DE, USA., Stevens E; Pfizer, Groton, CT, USA., Sun YS; Bristol Myers Squibb, Lawrenceville, NJ, USA., Tangri S; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Trampont PC; Moderna, Cambridge, MA, USA., Cludts I; UK MHRA, London, UK., Dysinger M; Alexion, New Haven, CT, USA., Kavita U; Spark Therapeutics, Plainsboro, NJ, USA., Sugimoto H; Takeda, Cambridge, MA, USA., Chilewski S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Grimaldi C; Regeneron, Tarrytown, NY, USA., Jiang Y; GlaxoSmithKline, Collegeville, PA, USA., Kamerud J; Pfizer, Andover, MA, USA., Liu S; Pfizer, Kirkland, QC, Canada., Owen C; Pfizer, Groton, CT, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Petit-Frere C; Fresenius Kabi, Bad Homburg, Germany., Pine S; Sanofi, Ghent, Belgium., Abhari MR; US FDA, Silver Spring, MD, USA., Scheibner K; US FDA, Silver Spring, MD, USA., Williams L; Bristol Myers Squibb, Lawrenceville, NJ, USA., Xu T; Frontage, Exton, PA, USA., Zhang G; Alnylam, Cambridge, MA, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2024; Vol. 16 (8), pp. 179-220. Date of Electronic Publication: 2024 May 22.