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24,668 results

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Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials.
Gupta S, Lau K, Harding CO, Shepherd G, Boyer R, Atkinson JP, Knight V, Olbertz J, Larimore K, Gu Z, Li M, Rosen O, Zoog SJ, Weng HH, Schweighardt B. Gupta S, et al. EBioMedicine. 2018 Nov;37:366-373. doi: 10.1016/j.ebiom.2018.10.038. Epub 2018 Oct 23. EBioMedicine. 2018. PMID: 30366815 Free PMC article. Clinical Trial.
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria.
Qi Y, Patel G, Henshaw J, Gupta S, Olbertz J, Larimore K, Harding CO, Merilainen M, Zori R, Longo N, Burton BK, Li M, Gu Z, Zoog SJ, Weng HH, Schweighardt B. Qi Y, et al. Among authors: gupta s. Clin Transl Sci. 2021 Sep;14(5):1894-1905. doi: 10.1111/cts.13043. Epub 2021 May 31. Clin Transl Sci. 2021. PMID: 34057292 Free PMC article. Clinical Trial.
Clinical immunogenicity outcomes from GENEr8-1, a phase 3 study of valoctocogene roxaparvovec, an AAV5-vectored gene therapy for hemophilia A.
Long BR, Robinson TM, Day JRS, Yu H, Lau K, Imtiaz U, Patton KS, de Hart G, Henshaw J, Agarwal S, Vettermann C, Zoog SJ, Gupta S. Long BR, et al. Among authors: gupta s. Mol Ther. 2024 Jul 3;32(7):2052-2063. doi: 10.1016/j.ymthe.2024.05.033. Epub 2024 May 24. Mol Ther. 2024. PMID: 38796703 Free article. Clinical Trial.
Pegvaliase for the treatment of phenylketonuria: Results of a long-term phase 3 clinical trial program (PRISM).
Thomas J, Levy H, Amato S, Vockley J, Zori R, Dimmock D, Harding CO, Bilder DA, Weng HH, Olbertz J, Merilainen M, Jiang J, Larimore K, Gupta S, Gu Z, Northrup H; PRISM investigators. Thomas J, et al. Among authors: gupta s. Mol Genet Metab. 2018 May;124(1):27-38. doi: 10.1016/j.ymgme.2018.03.006. Epub 2018 Mar 31. Mol Genet Metab. 2018. PMID: 29653686 Free article. Clinical Trial.
Hemangiomatous ameloblastoma; A separate entity?".
Sankar R, John S, Devi P, Verma S, Singh P, Gupta S. Sankar R, et al. Among authors: gupta s. Semin Diagn Pathol. 2025 Jan 10:S0740-2570(25)00002-4. doi: 10.1053/j.semdp.2025.01.003. Online ahead of print. Semin Diagn Pathol. 2025. PMID: 39863476 Review.
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).
Tounekti O, Prior S, Wassmer S, Xu J, Wong A, Fang X, Sonderegger I, Smeraglia J, Huleatt J, Loo L, Beaver C, DelCarpini J, Dessy F, Diebold S, Fiscella M, Garofolo F, Grimaldi C, Gupta S, Hou V, Irwin C, Jani D, Joseph J, Kalina W, Kar S, Kavita U, Lu Y, Marshall JC, Mayer C, Mora J, Nolan K, Peng K, Riccitelli N, Scully I, Seitzer J, Stern M, Wadhwa M, Xu Y, Verthelyi D, Sumner G, Clements-Egan A, Chen C, Gorovits B, Torri A, Baltrukonis D, Gunn G, Ishii-Watabe A, Kramer D, Kubiak RJ, Mullins G, Pan L, Partridge MA, Poetzl J, Rasamoelisolo M, Sirtori FR, Richards S, Saad OM, Shao W, Song Y, Song S, Staack RF, Wu B, Manangeeswaran M, Thacker S. Tounekti O, et al. Among authors: gupta s. Bioanalysis. 2025 Jan 25:1-45. doi: 10.1080/17576180.2024.2439229. Online ahead of print. Bioanalysis. 2025. PMID: 39862111
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