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2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (Part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).
Wojcik J, Sikorski T, Wang J, Huang Y, Sugimoto H, Baratta M, Ciccimaro E, Green R, Jian W, Kar S, Kim YJ, Lassman M, Mohapatra S, Qian M, Rosenbaum AI, Sarvaiya H, Tian Y, Vainshtein I, Yuan L, Tao L, Ji A, Kochansky C, Qiu H, Maes E, Chen LZ, Cooley M, Dufield D, Hyer E, Johnson J, Li W, Liu A, Lu Y, Meissen J, Palandra J, Tang X, Vigil A, Wei W, Vinter S, Xue Y, Yang L, Zheng N, Benson K, McCush F, Liang Z, Abberley L, Andisik M, Araya M, Cho SJ, Colligan L, Dasgupta A, Dudek M, Edmison A, Fischer S, Folian B, Garofolo F, Ishii-Watabe A, Ivanova D, Gijsel SK, Luo L, McGuinness M, 'Day CO, Salehzadeh-Asl R, Neto JT, Verhaeghe T, Wan K, Whale E, Yan W, Yang E, Zhang J. Wojcik J, et al. Among authors: kar s. Bioanalysis. 2025 Jan 25:1-39. doi: 10.1080/17576180.2025.2450194. Online ahead of print. Bioanalysis. 2025. PMID: 39862144
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: kar s. Bioanalysis. 2025 Jan 25:1-45. doi: 10.1080/17576180.2024.2439229. Online ahead of print. Bioanalysis. 2025. PMID: 39862111
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Bivi N, Graham D, Joglekar L, McGuire K, Stoop J, Zoghbi J, Baker B, Bandukwala A, Bond S, Buoninfante A, Chen J, Dysinger M, Engelbergs J, Fiscella M, Garofolo F, Hopper S, Jones B, King L, Murphy R, Palmer R, Sanderink G, Seyda A, Tang H, Van Tuyl A, Wagner L, Walravens K, Wang K, Zander H, Zhu L, Li M, Lin YD, Natalia M, Standifer N, Eck S, Goihberg P, Grugan K, Hedrick MN, Hopkins G, Kar S, Keller S, McGrath S, O'Gorman B, Stevens C, Stevens E, Terszowski G, Trampont PC, Yao S, Joyce A, Kumar S, Owen C, Pine S, Yearwood G, Cao L, Clausen V, Coble K, Culbert A, Gupta S, Hughes R, Liu S, Lu K, Martello R, Reese KJ, Stubenrauch KG, Wen Y. Bivi N, et al. Among authors: kar s. Bioanalysis. 2025 Jan 25:1-38. doi: 10.1080/17576180.2024.2442218. Online ahead of print. Bioanalysis. 2025. PMID: 39862107
Evaluating the global landscape of suicide helpline services: a global survey across 105 countries.
Vaghela G, Van Truong L, Trang VTT, Makram AM, Hung IC, Luu MN, Nam NH, Elsheikh R, Trieu MDT, Trang LTB, Khan Z, Ikeanyionwu CN, Makram EM, Duc NTM, Nguyen MH, Amanda TW, Baig Z, Chafee K, Fadel SY, Nguyen TK, Lamichhane A, Linh NNH, Khalil MH, Shidhaye R, Hasnain MA, Vijayakumar L, Mayne J, Maheen H, Kar SK, Onie S, Yip PSF, White J, Huy NT; Global Suicide Prevention Network Collaborators. Vaghela G, et al. Among authors: kar sk. Lancet Psychiatry. 2025 Feb;12(2):100-110. doi: 10.1016/S2215-0366(24)00354-7. Lancet Psychiatry. 2025. PMID: 39848729
2,657 results