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Neutralizing Antibody Validation Testing and Reporting Harmonization.
Myler, Heather; Pedras-Vasconcelos, João; Lester, Todd; Civoli, Francesca; Xu, Weifeng; Wu, Bonnie; Vainshtein, Inna; Luo, Linlin; Hassanein, Mohamed; Liu, Susana; Ramaswamy, Swarna Suba; Mora, Johanna; Pennucci, Jason; McCush, Fred; Lavelle, Amy; Jani, Darshana; Ambakhutwala, Angela; Baltrukonis, Daniel; Barker, Breann; Carmean, Rebecca; Chung, Shan; Dai, Sheng; DeWall, Stephen; Dholakiya, Sanjay L; Dodge, Robert; Finco, Deborah; Yan, Haoheng; Hays, Amanda; Hu, Zheng; Inzano, Cynthia; Kamen, Lynn; Lai, Ching-Ha; Meyer, Erik; Nelson, Robert; Paudel, Amrit; Phillips, Kelli; Poupart, Marie-Eve; Qu, Qiang; Abhari, Mohsen Rajabi; Ryding, Janka; Sheldon, Curtis; Spriggs, Franklin; Warrino, Dominic; Wu, Yuling; Yang, Lin; Pasas-Farmer, Stephanie.
Afiliación
  • Myler H; Bioanalytical and Biomarker Science and Technologies, Takeda, Cambridge, MA, 02139, USA. heather.myler@takeda.com.
  • Pedras-Vasconcelos J; 25 Creekview Ln, Yardley, Pennsylvania, 19067, USA. heather.myler@takeda.com.
  • Lester T; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20903, USA.
  • Civoli F; BioAgilytix Labs, Durham, North Carolina, 27713, USA.
  • Xu W; Coherus BioSciences, 333 Twin Dolphin Drive, Redwood City, California, 94065, USA.
  • Wu B; Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA.
  • Vainshtein I; Bioanalytical Discovery and Development Sciences, Janssen Research and Development, Spring House, Pennsylvania, 19477, USA.
  • Luo L; Discovery and Translational Research, Exelixis, 1851 Harbor Bay Pkwy, Alameda, California, 94502, USA.
  • Hassanein M; Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA.
  • Liu S; Early Clinical Development, Precision Medicine, Pfizer Inc, Cambridge, Massachusetts, USA.
  • Ramaswamy SS; Global Product Development, , Pfizer Inc, 17300 Trans Canada Hwy, Kirkland, Quebec, Canada.
  • Mora J; Regulated Bioanalysis Department, B2S Life Sciences, 97 East Monroe Street, Franklin, Indiana, 46131, USA.
  • Pennucci J; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • McCush F; Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA.
  • Lavelle A; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.
  • Jani D; Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.
  • Ambakhutwala A; Preclinical and Clinical Bioanalysis, , Moderna Tx, 200 Technology Square, Cambridge, Massachusetts, 02142, USA.
  • Baltrukonis D; Immunology Sciences, Kriya Therapeutics, 4105 Hopson Road, Morrisville, North Carolina, 27560, USA.
  • Barker B; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.
  • Carmean R; Drug Metabolism and Biopharmaceuticals, Incyte Corporation, 1801 Augustine Cut-Off, Wilmington, Delaware, 19803, USA.
  • Chung S; Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.
  • Dai S; Department of BioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA.
  • DeWall S; Quantitative Clinical Pharmacology & Translational Sciences (QCP), Daiichi Sankyo, Inc, 211 Mt. Airy Road, Basking Ridge, New Jersey, 07920, USA.
  • Dholakiya SL; Bioanalytical Sciences, Scholar Rock, 301 Binney Street, 3rd Floor, Cambridge, Massachusetts, 02142-1071, USA.
  • Dodge R; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Finco D; Novartis Institutes for BioMedical Research, 1 Health Plaza, East Hanover, New Jersey, 07936, USA.
  • Yan H; Deborah Finco Consulting LLC, 101 Prospect Hill Road, Groton, Connecticut, 06340, USA.
  • Hays A; Global Regulatory Affairs, Shanghai Henlius Biotech. Inc, 430 N. McCarthy Blvd, Milpitas, California, 95035, USA.
  • Hu Z; BioAgilytix Labs, Durham, North Carolina, 27713, USA.
  • Inzano C; Translation Safety & Bioanalytical Science, Amgen Inc, Thousand Oaks, California, 91360, USA.
  • Kamen L; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Lai CH; BioAgilytix Labs, Durham, North Carolina, 27713, USA.
  • Meyer E; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
  • Nelson R; Immunogenicity, GSK Pharmaceuticals, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA.
  • Paudel A; Bioanalytical Services, Labcorp Drug Development, Otley Road, Harrogate, HG3 1PY, UK.
  • Phillips K; Research Center Pharmaceutical Engineering GmbH (RCPE), Inffeldgasse 13, 8010, Graz, Austria.
  • Poupart ME; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.
  • Qu Q; Immunology, Charles River Laboratories, Montreal ULC, Transcanada Highway, Senneville, Quebec, 22022, Canada.
  • Abhari MR; Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA.
  • Ryding J; Office of Clinical PharmacologyOffice of Translational SciencesCenter for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Sheldon C; Bioanalysis-Biologics, Lundbeck A/S, Ottiliavej 9, 2500, Valby, Denmark.
  • Spriggs F; Technical Operations, , IVERIC Bio, Inc, 8 Sylvan Way, Parsippany, New Jersey, 07054, USA.
  • Warrino D; Spriggs Bioanalytical Consulting LLC, 15632 W 83rd Terrace, Lenexa, Kansas, 66219, USA.
  • Wu Y; Bioanalytical and Biomarker Services, KCAS, 10830 S Clay Blair Blvd, Olathe, Kansas, 66061, USA.
  • Yang L; Integrated Bioanalysis, , AstraZeneca, Gaithersburg, Maryland, 20878, USA.
  • Pasas-Farmer S; Bioanalytical Sciences, REGENXBIO Inc, 9804 Medical Center Drive, Rockville, Maryland, 20850, USA.
AAPS J ; 25(4): 69, 2023 07 08.
Article en En | MEDLINE | ID: mdl-37421491
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Anticuerpos Neutralizantes Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Anticuerpos Neutralizantes Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos