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Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.
Rup B, Pallardy M, Sikkema D, Albert T, Allez M, Broet P, Carini C, Creeke P, Davidson J, De Vries N, Finco D, Fogdell-Hahn A, Havrdova E, Hincelin-Mery A, C Holland M, H Jensen PE, Jury EC, Kirby H, Kramer D, Lacroix-Desmazes S, Legrand J, Maggi E, Maillère B, Mariette X, Mauri C, Mikol V, Mulleman D, Oldenburg J, Paintaud G, R Pedersen C, Ruperto N, Seitz R, Spindeldreher S, Deisenhammer F; ABIRISK Consortium. Rup B, et al. Clin Exp Immunol. 2015 Sep;181(3):385-400. doi: 10.1111/cei.12652. Epub 2015 Jul 2. Clin Exp Immunol. 2015. PMID: 25959571 Free PMC article. Review.
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A. Koren E, et al. Among authors: rup b. J Immunol Methods. 2008 Apr 20;333(1-2):1-9. doi: 10.1016/j.jim.2008.01.001. Epub 2008 Jan 29. J Immunol Methods. 2008. PMID: 18275969 Review.
Preclinical studies of recombinant factor IX.
Schaub R, Garzone P, Bouchard P, Rup B, Keith J, Brinkhous K, Larsen G. Schaub R, et al. Among authors: rup b. Semin Hematol. 1998 Apr;35(2 Suppl 2):28-32. Semin Hematol. 1998. PMID: 9565164 Review.
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J, Gupta S, Herzyk D, Hurst C, Ivens IA, Kawabata T, Maier C, Mounho B, Rup B, Shankar G, Smith H, Thomas P, Wierda D. Ponce R, et al. Among authors: rup b. Regul Toxicol Pharmacol. 2009 Jul;54(2):164-82. doi: 10.1016/j.yrtph.2009.03.012. Epub 2009 Apr 2. Regul Toxicol Pharmacol. 2009. PMID: 19345250
38 results