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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: joseph j. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L. Pan L, et al. Among authors: joseph j. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071 Free article.
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: joseph j. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500 Free article.
Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial.
Parker CC, Clarke NW, Cook AD, Kynaston H, Catton CN, Cross WR, Petersen PM, Persad RA, Saad F, Bower LC, Logue J, Payne H, Forcat S, Goldstein C, Murphy C, Anderson J, Barkati M, Bottomley DM, Branagan J, Choudhury A, Chung PWM, Cogley L, Goh CL, Hoskin P, Khoo V, Malone SC, Masters L, Morris SL, Nabid A, Ong AD, Raman R, Tarver KL, Tree AC, Worlding J, Wylie JP, Zarkar AM, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Parker CC, et al. Lancet. 2024 May 16:S0140-6736(24)00548-8. doi: 10.1016/S0140-6736(24)00548-8. Online ahead of print. Lancet. 2024. PMID: 38763154 Free article.
Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.
Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Parker CC, et al. Lancet. 2024 May 16:S0140-6736(24)00549-X. doi: 10.1016/S0140-6736(24)00549-X. Online ahead of print. Lancet. 2024. PMID: 38763153 Free article.
4,007 results