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Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
Jani, Darshana; Allinson, John; Berisha, Flora; Cowan, Kyra J; Devanarayan, Viswanath; Gleason, Carol; Jeromin, Andreas; Keller, Steve; Khan, Masood U; Nowatzke, Bill; Rhyne, Paul; Stephen, Laurie.
Affiliation
  • Jani D; Pfizer Inc., One Burtt Road, Andover, Massachusetts, 01810, USA. Darshana.Jani@pfizer.com.
  • Allinson J; LGC Ltd, Newmarket Road, Fordham, Cambridgeshire, CB7 5WW, UK.
  • Berisha F; Kyowa-Kirin Pharmaceuticals, 212 Carnegie Center #101, Princeton, New Jersey, 08540, USA.
  • Cowan KJ; Genentech, 1 DNA Way, South San Francisco, California, 94080, USA.
  • Devanarayan V; AbbVie Inc., 1 North Waukegan Road North, Chicago, Illinois, 60064, USA.
  • Gleason C; Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, New Jersey, 08540, USA.
  • Jeromin A; Quanterix Corporation, 113 Hartwell Avenue, Lexington, Massachusetts, 02421, USA.
  • Keller S; Abbvie Inc., 1500 Seaport Blvd, Redwood City, California, 94063, USA.
  • Khan MU; KCAS Bioanalytical and Biomarker Services, 12400 Shawnee Mission Parkway, Shawnee, Kansas, 66216, USA.
  • Nowatzke B; Radix Biosolutions, 111 Cooperative Way #120, Georgetown, Texas, 78626, USA.
  • Rhyne P; Quintiles Corporation, 1600 Terrell Mill Road Suite 100, Marietta, Georgia, 30067, USA.
  • Stephen L; Ampersand Biosciences, LLC, 3 Main St., Saranac Lake, New York, 12983, USA.
AAPS J ; 18(1): 1-14, 2016 Jan.
Article in En | MEDLINE | ID: mdl-26377333
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Ligands Type of study: Prognostic_studies Limits: Humans Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2016 Type: Article Affiliation country: United States
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Ligands Type of study: Prognostic_studies Limits: Humans Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2016 Type: Article Affiliation country: United States