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Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R; Coble, Kelly; Dholakiya, Sanjay L; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E; Irvin, Susan C; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D; Moldovan, Ioana R; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don.
Afiliação
  • Jani D; Bioanalytical and Molecular Assays, Moderna, Cambridge, Massachusetts, USA. Darshana.jani@modernatx.com.
  • Marsden R; Revelation Biosciences, California, USA.
  • Gunsior M; Research and Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA.
  • Hay LS; Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA.
  • Ward B; Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA.
  • Cowan KJ; New Biological Entities Drug Metabolism and Pharmacokinetics, Merck KGaA, Darmstadt, Germany.
  • Azadeh M; Biomarker Operations, Translational Medicine and Early Stage Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA.
  • Barker B; Drug Metabolism and Biopharmaceuticals, Incyte Corporation, Wilmington, Delaware, USA.
  • Cao L; Biomarker and BioAnalytical Sciences, Sangamo Therapeutics, California, USA.
  • Closson KR; Laboratory Operations, Immunologix Laboratories, Tampa, Florida, USA.
  • Coble K; DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
  • Dholakiya SL; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Dusseault J; Laboratory Sciences, Charles River Laboratories, Quebec, Canada.
  • Hays A; BioAgilytix, Durham, North Carolina, USA.
  • Herl C; Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA.
  • Hodsdon ME; Laboratory for Experimental Medicine, Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Irvin SC; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
  • Kirshner S; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kolaitis G; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Kulagina N; Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.
  • Kumar S; EMD Serono Research and Development Institute (A business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA.
  • Lai CH; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
  • Lipari F; Nexelis, a Q2 Solutions Company, Vaccine Sciences, Laval, Quebec, Canada.
  • Liu S; Global Product Development, Clinical Assay Group, Pfizer Inc., Kirkland, Quebec, Canada.
  • Merdek KD; Biomarkers and Clinical Bioanalyses (TMED), Sanofi, Framingham, Massachusetts, USA.
  • Moldovan IR; Cellular Technology Limited (CTL), Shaker Heights, Ohio, USA.
  • Mozaffari R; Bioanalysis, Immunogenicity and Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA.
  • Pan L; Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA.
  • Place C; DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
  • Snoeck V; Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
  • Manning MS; Translational Safety and Bioanalytical Sciences, Amgen Inc., Thousand Oaks, California, USA.
  • Stocker D; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Tary-Lehmann M; Cellular Technology Limited, Department Contract Laboratory, Shaker Heights, Ohio, USA.
  • Turner A; Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.
  • Vainshtein I; Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA.
  • Verthelyi D; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Williams WT; Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA.
  • Yan H; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yan W; Department of Bioanalytical Sciences, Genentech, South San Francisco, California, USA.
  • Yang L; Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA.
  • Yang L; Bioanalytical Sciences, REGENXBIO Inc., Rockville, Maryland, USA.
  • Zemo J; Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA.
  • Zhong ZD; Development Sciences, Denali Therapeutics, South San Francisco, California, USA.
AAPS J ; 24(6): 113, 2022 10 28.
Article em En | MEDLINE | ID: mdl-36307592
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Tipo de estudo: Guideline Idioma: En Revista: AAPS J Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Tipo de estudo: Guideline Idioma: En Revista: AAPS J Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos