作者:
Darshana,Jani [1]
;
Robin,Marsden [2]
;
Michele,Gunsior [3]
;
Laura Schild,Hay [4]
;
Bethany,Ward [4]
;
Kyra J,Cowan [5]
;
Mitra,Azadeh [6]
;
Breann,Barker [7]
;
Liching,Cao [8]
;
Kristin R,Closson [9]
;
Kelly,Coble [10]
;
Sanjay L,Dholakiya [11]
;
Julie,Dusseault [12]
;
Amanda,Hays [13]
;
Carina,Herl [14]
;
Michael E,Hodsdon [15]
;
Susan C,Irvin [16]
;
Susan,Kirshner [17]
;
Gerry,Kolaitis [11]
;
Nadia,Kulagina [18]
;
Seema,Kumar [19]
;
Ching Ha,Lai [16]
;
Francesco,Lipari [20]
;
Susana,Liu [21]
;
Keith D,Merdek [22]
;
Ioana R,Moldovan [23]
;
Reza,Mozaffari [24]
;
Luying,Pan [25]
;
Corina,Place [10]
;
Veerle,Snoeck [26]
;
Marta Starcevic,Manning [27]
;
Dennis,Stocker [11]
;
Magdalena,Tary-Lehmann [28]
;
Amy,Turner [18]
;
Inna,Vainshtein [14]
;
Daniela,Verthelyi [17]
;
William T,Williams [29]
;
Haoheng,Yan [17]
;
Weili,Yan [30]
;
Lili,Yang [25]
;
Lin,Yang [31]
;
Jennifer,Zemo [29]
;
Zhandong Don,Zhong [32]
作者单位:
Bioanalytical and Molecular Assays, Moderna, Cambridge, Massachusetts, USA. Darshana.jani@modernatx.com.
[1]
Revelation Biosciences, California, USA.
[2]
Research and Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA.
[3]
Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA.
[4]
New Biological Entities Drug Metabolism and Pharmacokinetics, Merck KGaA, Darmstadt, Germany.
[5]
Biomarker Operations, Translational Medicine and Early Stage Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA.
[6]
Drug Metabolism and Biopharmaceuticals, Incyte Corporation, Wilmington, Delaware, USA.
[7]
Biomarker and BioAnalytical Sciences, Sangamo Therapeutics, California, USA.
[8]
Laboratory Operations, Immunologix Laboratories, Tampa, Florida, USA.
[9]
DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
[10]
Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.
[11]
Laboratory Sciences, Charles River Laboratories, Quebec, Canada.
[12]
BioAgilytix, Durham, North Carolina, USA.
[13]
Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA.
[14]
Laboratory for Experimental Medicine, Eli Lilly and Company, Indianapolis, Indiana, USA.
[15]
Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.
[16]
Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
[17]
Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA.
[18]
EMD Serono Research and Development Institute (A business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA.
[19]
Nexelis, a Q2 Solutions Company, Vaccine Sciences, Laval, Quebec, Canada.
[20]
Global Product Development, Clinical Assay Group, Pfizer Inc., Kirkland, Quebec, Canada.
[21]
Biomarkers and Clinical Bioanalyses (TMED), Sanofi, Framingham, Massachusetts, USA.
[22]
Cellular Technology Limited (CTL), Shaker Heights, Ohio, USA.
[23]
Bioanalysis, Immunogenicity and Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA.
[24]
Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA.
[25]
Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
[26]
Translational Safety and Bioanalytical Sciences, Amgen Inc., Thousand Oaks, California, USA.
[27]
Cellular Technology Limited, Department Contract Laboratory, Shaker Heights, Ohio, USA.
[28]
Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA.
[29]
Department of Bioanalytical Sciences, Genentech, South San Francisco, California, USA.
[30]
Bioanalytical Sciences, REGENXBIO Inc., Rockville, Maryland, USA.
[31]
Development Sciences, Denali Therapeutics, South San Francisco, California, USA.
[32]
DOI
10.1208/s12248-022-00762-6
PMID
36307592
发布时间
2023-01-17
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