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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E. Shankar G, et al. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. J Pharm Biomed Anal. 2008. PMID: 18993008 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: shankar g. 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.
The quintessence of immunogenicity reporting for biotherapeutics.
Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. Shankar G, et al. Nat Biotechnol. 2015 Apr;33(4):334-6. doi: 10.1038/nbt.3181. Nat Biotechnol. 2015. PMID: 25850051 No abstract available.
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S; American Association of Pharmaceutical Scientists. Shankar G, et al. AAPS J. 2014 Jul;16(4):658-73. doi: 10.1208/s12248-014-9599-2. Epub 2014 Apr 24. AAPS J. 2014. PMID: 24764037 Free PMC article.
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: shankar g. 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
328 results