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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner, Giane; Keller, Steve; Huleatt, James; Staack, Roland F; Wagner, Leslie; Azadeh, Mitra; Bandukwala, Abbas; Cao, Liching; Du, Xiulian; Salinas, Gabriela Franco; Garofolo, Fabio; Harris, Shannon; Hopper, Shirley; Irwin, Chad; Ji, Qin; Joseph, Julie; King, Lindsay; Kinhikar, Arvind; Lu, Yang; Luo, Rosa; Mabrouk, Omar; Malvaux, Ludovic; Marshall, Jean-Claude; McGuire, Kristina; Mikol, Vincent; Neely, Robert; Qiu, Xiazi; Saito, Yoshiro; Salaun, Bruno; Scully, Ingrid; Smeraglia, John; Solstad, Therese; Stoop, Jeroen; Tang, Huaping; Teixeira, Priscila; Wang, Yixin; Wright, Mike; Mendez, Luis; Beaver, Chris; Eacret, Jacqueline; Au-Yeung, Amelia; Decman, Vilma; Dessy, Francis; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Gonneau, Christele; Grugan, Katharine; Hedrick, Michael Nathan; Kar, Sumit.
Afiliación
  • Sumner G; Regeneron, Tarrytown, NY, USA.
  • Keller S; AbbVie, South San Francisco, CA, USA.
  • Huleatt J; Sanofi Pasteur, Swiftwater, PA, USA.
  • Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Wagner L; US FDA, Silver Spring, MD, USA.
  • Azadeh M; Alkermes, Waltham, MA, USA.
  • Bandukwala A; US FDA, Silver Spring, MD, USA.
  • Cao L; Sangamo, Brisbane, CA, USA.
  • Du X; US FDA, Silver Spring, MD, USA.
  • Salinas GF; Janssen, Leiden, South Holland, Netherlands.
  • Garofolo F; BRI Frontage, Vancouver, BC, Canada.
  • Harris S; HilleVax, Cambridge, MA, USA.
  • Hopper S; UK MHRA, London, UK.
  • Irwin C; Health Canada, Ottawa, ON, Canada.
  • Ji Q; AbbVie, North Chicago, IL, USA.
  • Joseph J; Health Canada, Ottawa, ON, Canada.
  • King L; Pfizer, Cambridge, MA, USA.
  • Kinhikar A; Novartis, Cambridge, MA, USA.
  • Lu Y; US FDA, Silver Spring, MD, USA.
  • Luo R; Crinetics, San Diego, CA, USA.
  • Mabrouk O; Biogen, Cambridge, MA, USA.
  • Malvaux L; GSK Vaccines, Rixensart, Belgium.
  • Marshall JC; Moderna, Cambridge, MA, USA.
  • McGuire K; Regeneron, Tarrytown, NY, USA.
  • Mikol V; Sanofi, Vitry-sur-Seine, France.
  • Neely R; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • Qiu X; WRIB, Montreal, QC, Canada.
  • Saito Y; Japan MHLW, Tokyo, Japan.
  • Salaun B; GSK Vaccines, Rixensart, Belgium.
  • Scully I; Pfizer, Pearl River, NY, USA.
  • Smeraglia J; UCB, Braine-l'Alleud, Wallonia, Belgium.
  • Solstad T; Norway NoMA, Oslo, Norway.
  • Stoop J; Janssen, Leiden, South Holland, Netherlands.
  • Tang H; GlaxoSmithKline, Collegeville, PA, USA.
  • Teixeira P; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Wang Y; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • Wright M; GlaxoSmithKline, Stevenage, UK.
  • Mendez L; Merck, Kenilworth, NJ, USA.
  • Beaver C; Syneos Health, Toronto, ON, Canada.
  • Eacret J; Merck, West Point, PA, USA.
  • Au-Yeung A; Genentech, South San Francisco, CA, USA.
  • Decman V; GlaxoSmithKline, Philadelphia, PA, USA.
  • Dessy F; GSK Vaccines, Rixensart, Belgium.
  • Eck S; AstraZeneca, Gaithersburg, MD, USA.
  • Goihberg P; Pfizer, Andover, MA, USA.
  • Alcaide EG; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Gonneau C; Labcorp, Meyrin, Switzerland.
  • Grugan K; Janssen R&D, Spring House, Pa, USA.
  • Hedrick MN; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • Kar S; WRIB, Montreal, QC, Canada.
Bioanalysis ; 15(15): 861-903, 2023 Aug.
Article en En | MEDLINE | ID: mdl-37584363

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Bioensayo / Informe de Investigación Tipo de estudio: Guideline / Qualitative_research Idioma: En Revista: Bioanalysis Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Bioensayo / Informe de Investigación Tipo de estudio: Guideline / Qualitative_research Idioma: En Revista: Bioanalysis Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos