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Tissue bioanalysis of biotherapeutics and drug targets to support PK/PD.
Neubert H, Fountain S, King L, Clark T, Weng Y, O'Hara DM, Li W, Leung S, Ray C, Palandra J, Ocaña MF, Chen J, Ji C, Wang M, Long K, Gorovits B, Fluhler E. Neubert H, et al. Among authors: palandra j. Bioanalysis. 2012 Nov;4(21):2589-604. doi: 10.4155/bio.12.234. Bioanalysis. 2012. PMID: 23173794 Review.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S. Neubert H, et al. Among authors: palandra j. Bioanalysis. 2018 Dec;10(23):1897-1917. doi: 10.4155/bio-2018-0285. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488729 Free article. Review.
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Neubert H, Song A, Lee A, Wei C, Duggan J, Xu K, Woolf E, Evans C, Palandra J, Laterza O, Amur S, Berger I, Bustard M, Cancilla M, Chen SC, Cho SJ, Ciccimaro E, Cludts I, Cocea L, D'Arienzo C, Danan-Leon L, Donato LD, Garofolo F, Haidar S, Ishii-Watabe A, Jiang H, Kadavil J, Kassim S, Kurki P, Blaye OL, Liu K, Mathews R, Lima Santos GM, Niwa M, Pedras-Vasconcelos J, Qian M, Rago B, Saad O, Saito Y, Savoie N, Su D, Szapacs M, Tampal N, Vinter S, Wang J, Welink J, Whale E, Wilson A, Xue YJ. Neubert H, et al. Among authors: palandra j. Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205053 Free article.
Dystrophin and mini-dystrophin quantification by mass spectrometry in skeletal muscle for gene therapy development in Duchenne muscular dystrophy.
Farrokhi V, Walsh J, Palandra J, Brodfuehrer J, Caiazzo T, Owens J, Binks M, Neelakantan S, Yong F, Dua P, Le Guiner C, Neubert H. Farrokhi V, et al. Among authors: palandra j. Gene Ther. 2022 Nov;29(10-11):608-615. doi: 10.1038/s41434-021-00300-7. Epub 2021 Nov 5. Gene Ther. 2022. PMID: 34737451 Free PMC article.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. Kaur S, et al. Among authors: palandra j. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993 Free article.
29 results