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Page 1
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. Lowes S, et al. Among authors: lundberg r. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, Fang X. Boterman M, et al. Among authors: lundberg r. Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. Bioanalysis. 2012. PMID: 22452256 No abstract available.
4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
Lowes S, Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, Fang X. Lowes S, et al. Among authors: lundberg r. Bioanalysis. 2012 Apr;4(7):763-8. doi: 10.4155/bio.12.48. Bioanalysis. 2012. PMID: 22512795
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes S, Boterman M, Doig M, Breda M, Jersey J, Lelacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Zimmer J, Caturla MC, Couerbe P, Maltas J, Steffen R, Petrilla J, Safavi A, Awaiye K, Bhatti M, Sheldon C, Schiebl C, Struwe P, Turk D, Sangster T, Pattison C, Fast D, Goodwin L, Kamerud J, Dinan A, Mamelak D, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Folguera L, Zimmer D, Zimmermann T, Pawula M, Moussallie M, de Souza Teixeira L, Rocha T, Allinson J, Jardieu P, Tang D, Gouty D, Wright L, Truog J, Lin J, Yamashita Y, Khan M, Liu Y, Xu A, Lundberg R, Cox C, Breau A, Hayes R, Bigogno C, Schoutsen D, Dilger C, Jonker J, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Nicholson R, Jenkins R, Warren M, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, Fang X. Lowes S, et al. Among authors: lundberg r. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
Impact of prior CAR-T cell therapy on mosunetuzumab efficacy in patients with relapsed or refractory B-cell lymphomas.
Chong EA, Penuel E, Napier EB, Lundberg RK, Budde LE, Shadman M, Matasar MJ, Bartlett NL, Flinn IW, Bosch F, Fay K, Goy A, Kumar A, Nastoupil LJ, Wei MC, Wu M, Yin S, Fraietta JA, Chong ER, Schuster SJ. Chong EA, et al. Among authors: lundberg rk. Blood Adv. 2024 Nov 21:bloodadvances.2024013640. doi: 10.1182/bloodadvances.2024013640. Online ahead of print. Blood Adv. 2024. PMID: 39571171
Immunologic Predictors of Vaccine Responsiveness in Patients With Lymphoma and Chronic Lymphocytic Leukemia.
Chong EA, Kumashie KG, Chong ER, Fabrizio J, Gupta A, Svoboda J, Barta SK, Walsh KM, Napier EB, Lundberg RK, Nasta SD, Gerson JN, Landsburg DJ, Gonzalez J, Gaano A, Weirick ME, McAllister CM, Awofolaju M, John GN, Kammerman SC, Novacek J, Pajarillo R, Lundgreen KA, Tanenbaum N, Gouma S, Drapeau EM, Adamski S, D'Andrea K, Pattekar A, Hicks A, Korte S, Sharma H, Herring S, Williams JC, Hamilton JT, Bates P, Hensley SE, Prak ETL, Greenplate AR, Wherry EJ, Schuster SJ, Ruella M, Vella LA. Chong EA, et al. Among authors: lundberg rk. J Infect Dis. 2024 Jul 25;230(1):15-27. doi: 10.1093/infdis/jiae106. J Infect Dis. 2024. PMID: 39052709
Persistent T cell-mediated immune responses against Omicron variants after the third COVID-19 mRNA vaccine dose.
Belik M, Liedes O, Vara S, Haveri A, Pöysti S, Kolehmainen P, Maljanen S, Huttunen M, Reinholm A, Lundberg R, Skön M, Österlund P, Melin M, Hänninen A, Hurme A, Ivaska L, Tähtinen PA, Lempainen J, Kakkola L, Jalkanen P, Julkunen I. Belik M, et al. Among authors: lundberg r. Front Immunol. 2023 Jan 23;14:1099246. doi: 10.3389/fimmu.2023.1099246. eCollection 2023. Front Immunol. 2023. PMID: 36756112 Free PMC article.
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