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53 results

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Page 1
Clesrovimab for Prevention of RSV Disease in Healthy Infants.
Zar HJ, Simões EAF, Madhi SA, Ramilo O, Senders SD, Shepard JS, Laoprasopwattana K, Piedrahita J, Novoa JM, Vargas SL, Dionne M, Jackowska T, Liu E, Ishihara Y, Ikeda K, Zhang Y, Railkar RA, Lutkiewicz J, Vora KA, Zang X, Maas BM, Lee AW, Guerra A, Sinha A; CLEVER (MK-1654-004) Study Group. Zar HJ, et al. Among authors: railkar ra. N Engl J Med. 2025 Oct 2;393(13):1292-1303. doi: 10.1056/NEJMoa2502984. Epub 2025 Sep 17. N Engl J Med. 2025. PMID: 40961446 Clinical Trial.
A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants.
Madhi SA, Simões EAF, Acevedo A, Novoa Pizarro JM, Shepard JS, Railkar RA, Cao X, Maas BM, Zang X, Krick A, Roadcap B, Vora KA, Aliprantis AO, Lee AW, Sinha A. Madhi SA, et al. Among authors: railkar ra. J Infect Dis. 2025 Mar 17;231(3):e478-e487. doi: 10.1093/infdis/jiae581. J Infect Dis. 2025. PMID: 39601265 Free PMC article. Clinical Trial.
Quantification of clesrovimab, an investigational, half-life extended, anti-respiratory syncytial virus protein F human monoclonal antibody in the nasal epithelial lining fluid of healthy adults.
Phuah JY, Maas BM, Tang A, Zhang Y, Caro L, Railkar RA, Swanson MD, Cao Y, Li H, Roadcap B, Catchpole AP, Aliprantis AO, Vora KA. Phuah JY, et al. Among authors: railkar ra. Biomed Pharmacother. 2023 Dec 31;169:115851. doi: 10.1016/j.biopha.2023.115851. Epub 2023 Nov 14. Biomed Pharmacother. 2023. PMID: 37976891 Free article.
Clesrovimab in Infants and Children at Increased Risk for Severe RSV Disease.
Zar HJ, Bont LJ, Manzoni P, Muñoz FM, Ramilo O, Chen PY, Novoa JM, Ordoñez GA, Tsolia M, Tapiéro B, Acuña-Ávila MI, Castellanos JM, Meyer M, Morioka I, Chen Z, Railkar RA, Zang X, Maas BM, Likos A, Lee AW, Castagnini LA, Sinha A; SMART (MK-1654-007) Study Group. Zar HJ, et al. Among authors: railkar ra. N Engl J Med. 2025 Oct 2;393(13):1343-1345. doi: 10.1056/NEJMc2506107. Epub 2025 Sep 17. N Engl J Med. 2025. PMID: 40961423 No abstract available.
Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials.
Sinha A, Railkar RA, Castagnini L, Guerra A, Likos A, Lutkiewicz J, Maas BM, Zang X, Roadcap BA, Choi Y, Nahhas GJ, Arriola CS, Bont L, Manzoni P, Ramilo O, Muñoz FM, Finelli L, Lee AW. Sinha A, et al. Among authors: railkar ra. Contemp Clin Trials. 2025 Oct;157:107995. doi: 10.1016/j.cct.2025.107995. Epub 2025 Jun 30. Contemp Clin Trials. 2025. PMID: 40602662
Bayesian methods for the design and analysis of noninferiority trials.
Gamalo-Siebers M, Gao A, Lakshminarayanan M, Liu G, Natanegara F, Railkar R, Schmidli H, Song G. Gamalo-Siebers M, et al. Among authors: railkar r. J Biopharm Stat. 2016;26(5):823-41. doi: 10.1080/10543406.2015.1074920. Epub 2015 Aug 6. J Biopharm Stat. 2016. PMID: 26247350 Review.
Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer.
Ho M, Lazarovich A, Saoud R, Dahmen A, Tremblay S, Telfer S, Maruf M, Singer EA, Weiss RE, Jang TL, Elsamra SE, Merino M, Dolan R, Valera V, Rodriquez BW, Railkar R, Bellfield S, Stamatakis L, Shih J, Donahue RN, Navarro CP, Apolo AB, Gulley JL, Schlom J, Agarwal PK. Ho M, et al. Among authors: railkar r. Urol Oncol. 2025 Nov;43(11):660.e1-660.e10. doi: 10.1016/j.urolonc.2025.06.006. Epub 2025 Aug 7. Urol Oncol. 2025. PMID: 40781051 Clinical Trial.
"In-House" Data on the Outside-A Mobile Health Approach.
Huang Q, Crumley T, Walters C, Cluckers L, Heirman I, Railkar R, Bhatia G, Cantor M, Benko C, Izmailova ES, Rottey S, Stoch SA. Huang Q, et al. Among authors: railkar r. Clin Pharmacol Ther. 2020 Apr;107(4):948-956. doi: 10.1002/cpt.1790. Epub 2020 Mar 7. Clin Pharmacol Ther. 2020. PMID: 31955410 Clinical Trial.
53 results