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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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: malvaux l. 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: 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: malvaux l. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
MicroRNA-146a is a therapeutic target and biomarker for peripartum cardiomyopathy.
Halkein J, Tabruyn SP, Ricke-Hoch M, Haghikia A, Nguyen NQ, Scherr M, Castermans K, Malvaux L, Lambert V, Thiry M, Sliwa K, Noel A, Martial JA, Hilfiker-Kleiner D, Struman I. Halkein J, et al. Among authors: malvaux l. J Clin Invest. 2013 May;123(5):2143-54. doi: 10.1172/JCI64365. Epub 2013 Apr 24. J Clin Invest. 2013. PMID: 23619365 Free PMC article.
Real-time PCR has advantages over culture-based methods in identifying major airway bacterial pathogens in chronic obstructive pulmonary disease: Results from three clinical studies in Europe and North America.
Schoonbroodt S, Ichanté JL, Boffé S, Devos N, Devaster JM, Taddei L, Rondini S, Arora AK, Pascal T, Malvaux L. Schoonbroodt S, et al. Among authors: malvaux l. Front Microbiol. 2023 Feb 24;13:1098133. doi: 10.3389/fmicb.2022.1098133. eCollection 2022. Front Microbiol. 2023. PMID: 36909845 Free PMC article.
Prevention of vaccine-matched and mismatched influenza in children aged 6-35 months: a multinational randomised trial across five influenza seasons.
Claeys C, Zaman K, Dbaibo G, Li P, Izu A, Kosalaraksa P, Rivera L, Acosta B, Arroba Basanta ML, Aziz A, Cabanero MA, Chandrashekaran V, Corsaro B, Cousin L, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Friel D, Garcia-Sicilia J, Gomez-Go GD, Antoinette Gonzales ML, Hughes SM, Jackowska T, Kant S, Lucero M, Malvaux L, Mares Bermudez J, Martinon-Torres F, Miranda M, Montellano M, Peix Sambola MA, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Salamanca de la Cueva I, Sokal E, Soni J, Szymanski H, Ulied A, Schuind A, Jain VK, Innis BL; Flu4VEC Study Group. Claeys C, et al. Among authors: malvaux l. Lancet Child Adolesc Health. 2018 May;2(5):338-349. doi: 10.1016/S2352-4642(18)30062-2. Epub 2018 Mar 5. Lancet Child Adolesc Health. 2018. PMID: 30169267 Clinical Trial.