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Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler, Heather; Pedras-Vasconcelos, João; Phillips, Kelli; Hottenstein, Charles Scott; Chamberlain, Paul; Devanaryan, Viswanath; Gleason, Carol; Goodman, Joanne; Manning, Marta Starcevic; Purushothama, Shobha; Richards, Susan; Shen, Honglue; Zoghbi, Jad; Amaravadi, Lakshmi; Barger, Troy; Bowen, Steven; Bowsher, Ronald R; Clements-Egan, Adrienne; Geng, Dong; Goletz, Theresa J; Gunn, George R; Hallett, William; Hodsdon, Michael E; Janelsins, Brian M; Jawa, Vibha; Kamondi, Szilard; Kirshner, Susan; Kramer, Daniel; Liang, Meina; Lindley, Kathryn; Liu, Susana; Liu, ZhenZhen; McNally, Jim; Mikulskis, Alvydas; Nelson, Robert; Ahbari, Mohsen Rajabi; Qu, Qiang; Ruppel, Jane; Snoeck, Veerle; Song, An; Yan, Haoheng; Ware, Mark.
Affiliation
  • Myler H; Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppdi.com.
  • Pedras-Vasconcelos J; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Phillips K; Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.
  • Hottenstein CS; Immunogenicity, GlaxoSmithKline Pharmaceuticals, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA.
  • Chamberlain P; NDA Advisory Services, Ltd., Grove House, Guildford Road, Leatherhead, KT22 9DF, Surrey, UK.
  • Devanaryan V; Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, USA.
  • Gleason C; Global Biometric and Data Sciences, Bristol-Myers Squibb, Princeton, New Jersey, 08540, USA.
  • Goodman J; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
  • Manning MS; Bioanalytical Sciences, Amgen Research, Thousand Oaks, California, 91320, USA.
  • Purushothama S; Diagnostics Accelerator, Alzheimer's Drug Discovery Foundation, 57W 57th Street, New York, New York, USA.
  • Richards S; Translational Medicine and Early Development, Sanofi, Framingham, Massachusetts, 01701, USA.
  • Shen H; Specialty Bioanalytics, Teva Pharmaceuticals, West Chester, Pennsylvania, 19380, USA.
  • Zoghbi J; Translational Medicine and Early Development, Sanofi, Framingham, Massachusetts, 01701, USA.
  • Amaravadi L; Shire Plc- a Takeda Company, Cambridge, Massachusetts, 02142, USA.
  • Barger T; Bioanalytical Sciences, Amgen Research, Thousand Oaks, California, 91320, USA.
  • Bowen S; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Bowsher RR; B2S Life Sciences, 97 East Monroe Street, Franklin, Indiana, 46131, USA.
  • Clements-Egan A; Janssen BioTherapeutics, Janssen R&D LLC, Spring House, Pennsylvania, 19477, USA.
  • Geng D; Legend Biotech, 10 Knightsbridge Road, Piscataway, New Jersey, 08554, USA.
  • Goletz TJ; Drug Metabolism & Pharmacokinetics, EMD Serono, Billerica, Massachusetts, 01821, USA.
  • Gunn GR; Immunogenicity, GlaxoSmithKline Pharmaceuticals, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA.
  • Hallett W; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Hodsdon ME; Laboratory for Experimental Medicine, Eli Lilly and Company, Indianapolis, Indiana, 46285, USA.
  • Janelsins BM; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Jawa V; Predictive and Clinical Immunogenicity Pharmacometrics, Pharmacodynamics and Drug Metabolism, Merck and Co., 2000 Galloping Hill Road, Kenilworth, New Jersey, 07033, USA.
  • Kamondi S; Kamondi Bioanalytical Consultancy, Rheinfelden, Switzerland / Roche Pharma Research & Early Development, Pharmaceutical Sciences, Bioanalytical R&D, Roche Innovation Center, Basel, Switzerland.
  • Kirshner S; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Kramer D; Translational Medicine and Early Development, Sanofi, Frankfurt am Main, Germany.
  • Liang M; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, California, USA.
  • Lindley K; BioAgilytix Labs, Durham, North Carolina, 27713, USA.
  • Liu S; Pfizer Inc., 17300 Trans Canada Hwy, Kirkland, Quebec, Canada.
  • Liu Z; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • McNally J; BioAgilytix Labs, Durham, North Carolina, 27713, USA.
  • Mikulskis A; Clinical Biomarkers, Vertex Pharmaceuticals, Inc., Boston, Massachusetts, 02210, USA.
  • Nelson R; Immunochemistry Department, Covance Laboratories Ltd., Harrogate, HG3 1PY, UK.
  • Ahbari MR; Office of Study Integrity and Surveillance, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Qu Q; Global Product Development, Pfizer Inc., Andover, Massachusetts, 01810, USA.
  • Ruppel J; BioAnalytical Sciences, Genentech, South San Francisco, California, USA.
  • Snoeck V; Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, B-1420, Braine-l'Alleud, Belgium.
  • Song A; Development Sciences, Immune-Onc Therapeutics, Palo Alto, California, 94303, USA.
  • Yan H; Product Quality and Immunogenicity, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Ware M; Janssen BioTherapeutics, Janssen R&D LLC, Spring House, Pennsylvania, 19477, USA.
AAPS J ; 24(1): 4, 2021 12 01.
Article de En | MEDLINE | ID: mdl-34853961
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Dosage biologique / Anticorps Pays/Région comme sujet: America do norte / Europa Langue: En Journal: AAPS J Sujet du journal: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Année: 2021 Type de document: Article Pays d'affiliation: États-Unis d'Amérique Pays de publication: États-Unis d'Amérique
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Dosage biologique / Anticorps Pays/Région comme sujet: America do norte / Europa Langue: En Journal: AAPS J Sujet du journal: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Année: 2021 Type de document: Article Pays d'affiliation: États-Unis d'Amérique Pays de publication: États-Unis d'Amérique