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Daniela Verthelyi

drug evaluation and research

45H指数
149论文数
7.6K被引数
收录论文 70
发表时间
Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products2024年FDA-CRCG研讨会论文集:评估仿制肽类和寡核苷酸药物产品免疫原性风险的科学与监管考量
err2026-02-12
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PREAI
errJennifer K. Lee; Ha-Na Lee; Sudhir Agrawal; Joseph A. Balsamo; Andrew Clerman; Sofie Denies; Anne De Groot; Jeremy Fry; Nicolas Gaudenzio; Andrew J. Graves; Kristina E. Howard; SuJin Hwang; Vibha Jawa; Yafei Jin; Logan Kelly-Baker; Emilee Knowlton; Filip Kolenc; Kirthiram Krishnaveni Sivakumar; Jae H. Lee; Yili Li; Likan Liang; Dahui Liu; Yanyan Liu; Robert Lionberger; Markham C. Luke; Mohanraj Manangeeswaran; Mirian Mendoza; Iilun Murphy; Michael Norcross; James E. Polli; Montserrat Puig; Narasimha Rao SP; Hobart Rogers; Anna Schwendeman; Robert Siegel; Sophie Shubow; Noel Smith; Seth G. Thacker; Sophie Tourdot; Kui Yang; Li Zhang; Deyi Zhang; Cameron J. Smith; Eric S. Pang; Daniela Verthelyi
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Proceedings of the 15th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals第十五届欧洲生物药免疫原性平台公开研讨会的会议录
errMABS
IF7.3
err2025-04-03
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errOAAI
errSophie Tourdot; Karien Bloem; Lysie Champion; Anne S. De Groot; Axel Ducret; Patrick Garidel; Joanna Grudzinska-Goebel; Michael Gutknecht; Timothy Hickling; Frank Horling; Marina Ichetovkin; Alison Johnson; Issa Jyamubandi; Anette Karle; Arno Kromminga; Ebru Aydin Kurtulmus; Floris Loeff; Bernard Maillere; Lydia Michaut; Francesca Minelli; Morten Nielsen; Vivek Nayak; Robert Nelson; Marc Pallardy; Sofie Pattyn; Joao Pedras-Vasconelos; Elise Pepermans; Alain Poyau; Matthias Reichel; Amy Rosenberg; Zuben Sauna; Manisha Saxena; Noel Smith; Veerle Snoeck; Lester Thoo; Michael Tovey; Daniela Verthelyi; Rene Wuttke; Daniel Yerly; Daniel Kramer
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Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin
err2024-12-20
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errOAAI
errHer, Cheng; Thacker, Seth; Balsamo, Joseph; Kelley Baker, Logan; Ireland, Derek D. C.; Pang, Eric; Verthelyi, Daniela
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Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024)
err2024-09-04
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errOAAI
errJani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin
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Neutralizing Antibody Sample Testing and Report Harmonization
err2024-07-12
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errOAAI
errJani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin
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Ebola virus-induced eye sequelae: a murine model for evaluating glycoprotein-targeting therapeutics
err2024-06-01
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errOAAI
errLee, Ha-Na; Xu, Biying; Lewkowicz, Aaron P.; Engel, Kaliroi; Kelley-Baker, Logan; McWilliams, Ian L.; Ireland, Derek D. C.; Kielczewski, Jennifer L.; Li, Jinbo; Fariss, Robert N.; Campos, Mercedes M.; Baum, Alina; Kyratsous, Christos; Pascal, Kristen; Chan, Chi-Chao; Caspi, Rachel R.; Manangeeswaran, Mohanraj; Verthelyi, Daniela
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Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals
errMABS
IF7.3
err2024-03-05
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errOAAI
errTourdot, Sophie; Baltrunkonis, Daniel; Denies, Sofie; Devanarayan, Viswanath; Grudzinska-Goebel, Joanna; Kromminga, Arno; Lotz, Gregor P.; Malherbe, Laurent; Michaut, Lydia; Weldingh, Karin N.; Pedras-Vasconcelos, Joao A.; Salazar-Fontana, Laura. I.; Spindeldreher, Sebastian; Sauna, Zuben; Snoeck, Veerle; Verthelyi, Daniela; Kramer, Daniel
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Neonatal Zika virus infection causes transient perineuronal net degradation
err2023-07-11
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errOAAI
errEngel, Kaliroi; Lee, Ha-Na; Tewari, Bhanu P.; Lewkowicz, Aaron P.; Ireland, Derek D. C.; Manangeeswaran, Mohanraj; Verthelyi, Daniela
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Anti-drug Antibody Sample Testing and Reporting Harmonization
err2022-10-28
err7
errOAAI
errJani, 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
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Association of complement component 4 with neuroimmune abnormalities in the subventricular zone in schizophrenia and autism spectrum disorders
err2022-10-01
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errOAAI
errMou, Ta-Chung M.; Lane, Malcolm, V; Ireland, Derek D. C.; Verthelyi, Daniela; Tonelli, Leonardo H.; Clark, Sarah M.
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Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs评估基于寡核苷酸的药物的免疫原性潜力
err2022-10-01
err7
PREAI
errHenry, Scott P.; Arfvidsson, Cecilia; Arrington, Josh; Canadi, Jasna; Crowe, Dave; Gupta, Shalini; Lohmann, Sabine; Massonnet, Benoit; Mytych, Daniel; Rogers, Tina; Rogers, Hobart; Stebbins, Chris; Stovold, Craig; Verthelyi, Daniela; Vigil, Adam; Xuan, Chi; Xu, Yuanxin; Yu, Rosie; Klem, Thomas
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Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients
err2022-09-06
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errOAAI
errThacker, Seth G.; Her, Cheng; Kelley-Baker, Logan; Ireland, Derek D. C.; Manangeeswaran, Mohanraj; Pang, Eric S.; Verthelyi, Daniela
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BSL2-compliant lethal mouse model of SARS-CoV-2 and variants of concern to evaluate therapeutics targeting the Spike protein
err2022-07-28
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errOAAI
errManangeeswaran, Mohanraj; Ireland, Derek D. C.; Thacker, Seth G.; Lee, Ha-Na; Kelley-Baker, Logan; Lewkowicz, Aaron P.; Rothlauf, Paul W.; Cornejo Pontelli, Marjorie; Bloyet, Louis-Marie; Eckhaus, Michael A.; Mendoza, Mirian I.; Whelan, Sean; Verthelyi, Daniela
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NK cells require immune checkpoint receptor LILRB4/gp49B to control neurotropic Zika virus infections in mice
err2022-02-08
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errOAAI
errLee, Ha-Na; Manangeeswaran, Mohanraj; Lewkowicz, Aaron P.; Engel, Kaliroi; Chowdhury, Monica; Garige, Mamatha; Eckhaus, Michael A.; Sourbier, Carole; Ireland, Derek D. C.; Verthelyi, Daniela
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An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide
err2021-12-09
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errOAAI
errHolley, Claire K.; Cedrone, Edward; Donohue, Duncan; Neun, Barry W.; Verthelyi, Daniela; Pang, Eric S.; Dobrovolskaia, Marina A.
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Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations
err2021-11-29
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errOAAI
errPegues, Melissa A.; Szczepanek, Karol; Sheikh, Faruk; Thacker, Seth G.; Aryal, Baikuntha; Ghorab, Mohamed K.; Wolfgang, Steven; Donnelly, Raymond P.; Verthelyi, Daniela; Rao, V. Ashutosh
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Characterization of the therapeutic effect of antibodies targeting the Ebola glycoprotein using a novel BSL2-compliant rVSVΔG-EBOV-GP infection model
err2021-11-10
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errOAAI
errLee, Ha-Na; McWilliams, Ian L.; Lewkowicz, Aaron P.; Engel, Kaliroi; Ireland, Derek D. C.; Kelley-Baker, Logan; Thacker, Seth; Piccardo, Pedro; Manangeeswaran, Mohanraj; Verthelyi, Daniela
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Lessons learned: new insights on the role of cytokines in COVID-19经验教训: 关于细胞因子在新型冠状病毒肺炎中的作用的新见解
err2021-03-15
err69
errOAAI
errBuszko, Maja; Nita-Lazar, Aleksandra; Park, Jung-Hyun; Schwartzberg, Pamela L.; Verthelyi, Daniela; Young, Howard A.; Rosenberg, Amy S.
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