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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: azadeh m. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. Spitz S, et al. Among authors: azadeh m. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867 Free article.
Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani D, Marsden R, Gunsior M, Hay LS, Ward B, Cowan KJ, Azadeh M, Barker B, Cao L, Closson KR, Coble K, Dholakiya SL, Dusseault J, Hays A, Herl C, Hodsdon ME, Irvin SC, Kirshner S, Kolaitis G, Kulagina N, Kumar S, Lai CH, Lipari F, Liu S, Merdek KD, Moldovan IR, Mozaffari R, Pan L, Place C, Snoeck V, Manning MS, Stocker D, Tary-Lehmann M, Turner A, Vainshtein I, Verthelyi D, Williams WT, Yan H, Yan W, Yang L, Yang L, Zemo J, Zhong ZD. Jani D, et al. Among authors: azadeh m. AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6. AAPS J. 2022. PMID: 36307592
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Hays A, Wissel M, Colletti K, Soon R, Azadeh M, Smith J, Doddareddy R, Chalfant M, Adamowicz W, Ramaswamy SS, Dholakiya SL, Guelman S, Gullick B, Durham J, Rennier K, Nagilla P, Muruganandham A, Diaz M, Tierney C, John K, Valentine J, Lockman T, Liu HY, Moritz B, Ouedraogo JP, Piche MS, Smet M, Murphy J, Koenig K, Zybura A, Vyhlidal C, Mercier J, Jani N, Kubista M, Birch D, Morse K, Johansson O. Hays A, et al. Among authors: azadeh m. AAPS J. 2024 Feb 5;26(1):24. doi: 10.1208/s12248-023-00880-9. AAPS J. 2024. PMID: 38316745
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
Gorovits B, Azadeh M, Buchlis G, Fiscella M, Harrison T, Havert M, Janetzki S, Jawa V, Long B, Mahnke YD, McDermott A, Milton M, Nelson R, Vettermann C, Wu B. Gorovits B, et al. Among authors: azadeh m. AAPS J. 2023 Apr 26;25(3):47. doi: 10.1208/s12248-023-00814-5. AAPS J. 2023. PMID: 37101079 Free PMC article. Review.
Transcription Analysis of the THBS2 Gene through Regulation by Potential Noncoding Diagnostic Biomarkers and Oncogenes of Gastric Cancer in the ECM-Receptor Interaction Signaling Pathway: Integrated System Biology and Experimental Investigation.
Barani A, Beikverdi K, Mashhadi B, Parsapour N, Rezaei M, Javid P, Azadeh M. Barani A, et al. Among authors: azadeh m. Int J Genomics. 2023 Dec 22;2023:5583231. doi: 10.1155/2023/5583231. eCollection 2023. Int J Genomics. 2023. PMID: 38162289 Free PMC article.
Synaptic proteins in neuron-derived extracellular vesicles as biomarkers for Alzheimer's disease: novel methodology and clinical proof of concept.
Eitan E, Thornton-Wells T, Elgart K, Erden E, Gershun E, Levine A, Volpert O, Azadeh M, Smith DG, Kapogiannis D. Eitan E, et al. Among authors: azadeh m. Extracell Vesicles Circ Nucl Acids. 2023 Mar;4(1):133-150. doi: 10.20517/evcna.2023.13. Epub 2023 Mar 31. Extracell Vesicles Circ Nucl Acids. 2023. PMID: 37842184 Free PMC article.
43 results