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Utilizing design of experiments to characterize assay robustness.
Cowan KJ, Erickson R, Sue B, Delarosa R, Gunter B, Coleman DA, Gilbert H, Song A, Fischer SK. Cowan KJ, et al. Among authors: fischer sk. Bioanalysis. 2012 Sep;4(17):2127-39. doi: 10.4155/bio.12.199. Bioanalysis. 2012. PMID: 23013395
Commercial biomarker assays: friend and foe.
Fischer SK, Carrasco-Triguero M, Hong K, Good J, Davancaze T, Nguy T, Li J, Darbonne W, Morimoto A, Zhu Y. Fischer SK, et al. Bioanalysis. 2016 Nov;8(22):2351-2362. doi: 10.4155/bio-2016-0183. Epub 2016 Oct 5. Bioanalysis. 2016. PMID: 27704870
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Review.
An in vitro FcRn- dependent transcytosis assay as a screening tool for predictive assessment of nonspecific clearance of antibody therapeutics in humans.
Chung S, Nguyen V, Lin YL, Lafrance-Vanasse J, Scales SJ, Lin K, Deng R, Williams K, Sperinde G, Li JJ, Zheng K, Sukumaran S, Tesar D, Ernst JA, Fischer S, Lazar GA, Prabhu S, Song A. Chung S, et al. MAbs. 2019 Jul;11(5):942-955. doi: 10.1080/19420862.2019.1605270. Epub 2019 Apr 29. MAbs. 2019. PMID: 30982394 Free PMC article.
60 results