Not logged inIndustry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs)
Wuchner, Klaus; Riesop, David; Huon, Carine; Mudumala, Prudvi Raj; Steffen, Jean-Sebastien; Kuhn, Sebastian M.; Mayer, Tobias; Rass, Sophia; Neuhold, Karen; Spreng, Ben; Hebting, Henri
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SaveEvaluating pertussis vaccine effectiveness in children under 5 years of age born in France between 2013 and 2019
Vargas-Zambrano, Juan C.; Arnaud, Mickael; Antunes, Ana; Karzazi, Khalil; Despres, Johanna; Verdier, Regis; Boisnard, Florence; Jund, Jerome; Janssen, Cecile; Pinquier, Didier; Macina, Denis
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SaveImmunogenicity and Safety of vYF, a Yellow Fever Vaccine - A Phase 2 Trial
Feroldi, Emmanuel; Mulligan, Mark J.; Talaat, Kawsar R.; Tan, Chen Sabrina; Paolino, Kristopher; Edupuganti, Srilatha; Collins, Matthew H.; George, Sarah L.; Davis, Matthew; Essink, Brandon; Jeanfreau, Robert; Peterson, James; Fried, David; Minutello, Ada-Maria; Orlando, Sandrine; Korejwo, Joanna; Rojas, Andrey; Dufournet, Marine; Machabert, Tifany; Devlin, Louis; Frago, Carina
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SaveMethyl-specific NMR of therapeutic antibodies: cost-effective isotopic labeling strategies in CHO cells for high-resolution structural characterization
Awad, Rida; Giraud, Arthur; Vibert, Beatrice; Clavier, Severine; Le Borgne, Helene; Macon, Laetitia; Muhr-Naninck, Anais; Seguin-Huet, Stephanie; Mothes, Benoit; Gans, Pierre; Frances, Oriane; Boisbouvier, Jerome; Crublet, Elodie
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SaveReal-world, long-term effectiveness of dupilumab treatment in patients with severe asthma: 2 years of the ProVENT study
Lommatzsch, Marek; Schmidt, Olaf; Timmermann, Hartmut; Gappa, Monika; Watz, Henrik; Kwah, Jason; Ledanois, Olivier; Nischan, Nicole; Hahn, Matthias; Heimann, Andreas; Korn, Stephanie
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SaveSelective Depletion of Autoreactive Plasma Cells as a Novel Strategy to Treat Acetylcholine Receptor Antibody-Positive Myasthenia Gravis
Khodadadi, Laleh; Puppe, Deborah; Cirillo, Dilara S.; Martinez-Cingolani, Carolina; Klotsche, Jens; Pelz, Andreas; Kohler, Siegfried; Cheng, Qingyu; Lazaridis, Konstantinos; Fichtner, Michael; Pille, Jan; Kruglov, Andrey; Bondareva, Marina; Alexander, Tobias; Radbruch, Andreas; Meisel, Andreas; Hiepe, Falk
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SaveModeling, Simulation, and Extrapolation to Optimize Pediatric Development Plan: Sarilumab Polyarticular-Course juvenile arthritis Application
Xu, Christine; Zhang, Mei; Liu, Ying; Baret-Cormel, Lydie; De Benedetti, Fabrizio; Abdallah, Hisham; Kanamaluru, Vanaja; Meng, Zhaoling
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SaveTreatment of Haemophilia A Without Inhibitors: Real-World Treatment Patterns and Clinical Outcomes in the US
Wheeler, Allison P.; Amos, Lauren E.; Gupta, Shveta; Bozzi, Sylvie; Miles, Gandarvaka; Hawaldar, Kalyani; Wilson, Andrew; Hanson, Gillian; Cibelli, Emily; Wilson, Amanda; Umarje, Siddhi; Tardy, Anne-laure; Dumont, Jennifer; Neill, Graham; Arnaud, Alix
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Save2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (PART 1A-Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting PART 1B-Regulatory Agencies' Input on Regulated Bioanalysis/BMV)
Wojcik, John; Qian, Mark; Rosenbaum, Anton I.; Maes, Estelle; Xue, Yongjun; Kochansky, Christopher; Boer, Jason; Chen, Linzhi; Descloux, Sandrine; Garofolo, Fabio; Johnson, Jay; Kaur, Surinder; Lassman, Michael; Mcgregor, Jessica; O'callaghan, Lisa; Sikorski, Timothy; Wan, Katty; Wang, Shunhai; Zheng, Naiyu; Zhang, Guodong; Hoover, Michael; Wang, Jian; Yuan, Long; Ji, Qin; Jones, Barry; Boyanapalli, Ramakrishna; Chen, Jian; Dobson, Christine; Dong, Linlin; Ferrari, Luca; Fu, Yunlin; Gong, Chao; Ivanova, Dany; Li, Jing; Licea-Perez, Hermes; Liu, Aihua; Tang, Xiaonan; Tao, Lin; Tweed, Joseph; Eddy, John; Francis, Jennifer; Kavetska, Olga; Araya, Marcela; Foley, Timothy; Andisik, Matthew; Belfast, Mary; Borbridge, Lisa; Cho, Seongeun (julia); Colligan, Liliana; Dasgupta, Arindam; Edmison, Anna; Fandozzi, Christine; Galliccia, Fabrizio; Kim, Yeoun Jin; Lu, Yang; Massip, Anne-Marie; Shakleya, Diaa; Tampal, Nilufer; Neto, Joao Tavares; Thomas, Justina; Wang, Jin; Wang, Linna; Wang, Ying; Whale, Emma; Wiberg, Megan; Yang, Li
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SaveAssessment of greenhouse gas emission of type 2 diabetes management in adults: a modelling study in the UK
Lund, Niels; Maslova, Ekaterina; Chen, Jieling; Giannini, Julia; Soro, Mar; Culligan, Ian; Richards, Glyn; Taneja, Loveleen; Varghese, Shanky; Li, Yuxin; Xu, Weiwei; Gonzalez, Jose; Valentim, Joice; De La Tour, Priscille; Adshead, Fiona; Moore, Keith; Puggina, Anna
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SaveObefazimod enhances miR-124 expression in blood and colon tissue and reduces the key inflammatory cytokines IL-17A and IL-6 in serum of patients with moderate-to-severely active ulcerative colitis: results from the Phase 3 ABTECT induction trials
Siegmund, B.; Danese, S.; Dubinsky, M. C.; Atreya, R.; Abecassis-Borgus, A.; Apolit, C.; Sandri, J.; Belda, C.; Amin, P.; Santo, J.; Mosig, R.; Jacobstein, D.; Cataldi, F.; Rabbat, C.; Howaldt, S.; Verstockt, B.; D'Haens, G.; Dulai, P.
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SavePooled analysis of efficacy and safety of once-daily oral obefazimod in European patients from the ABTECT Phase 3, double-blind, placebo-controlled induction trials
Scaldaferri, F.; Seidler, U.; Treton, X.; D'Amico, F.; Armuzzi, A.; Howaldt, S.; Heeren, S.; Atreya, R.; Baert, F. J.; Tilg, H.; Cataldi, F.; Jacobstein, D.; Rabbat, C.; Shan, K.; Cicala, M.
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SaveImprovements in patient-reported work productivity and activity impairment among patients with moderately to severely active ulcerative colitis (UC) treated with obefazimod induction therapy: pooled results from the 8-week ABTECT-1 and ABTECT-2 Phase 3, double-blind, placebo-controlled induction trials
Tilg, H.; Dulai, P.; Skybalo, S.; Neshta, V; Howaldt, S.; D'amico, F.; Gregus, M.; Rabbat, C.; Fine, J. T.; Shan, K.; Dolan, C. M.; Jacobstein, D.; Cataldi, F.; Siegmund, B.
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SaveImpact of baseline Mayo endoscopic subscore on the efficacy of once-daily oral obefazimod in moderately to severely active ulcerative colitis: week 8 results from the two Phase 3 ABTECT induction trials
Peyrin-Biroulet, L.; Sands, B. E.; Armuzzi, A.; Cataldi, F.; Jacobstein, D.; Rabbat, C.; Shan, K.; Toeroek, H.; Nancey, S.; D'haens, G.; Laharie, D.; Dubinsky, M. C.
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SaveImpact of prior advanced therapy inadequate response by drug class on symptomatic improvement with obefazimod in patients with moderately to severely active ulcerative colitis: pooled analysis of ABTECT Phase 3 induction trials
Danese, S.; Sands, B. E.; Heeren, S.; Schnabel, R.; Cataldi, F.; Jacobstein, D.; Rabbat, C.; Shan, K.; Gregus, M.; Sparrow, M. P.; Rubin, D. T.
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