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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. Among authors: devanarayan v. 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 for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.
Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA. Mire-Sluis AR, et al. Among authors: devanarayan v. J Immunol Methods. 2004 Jun;289(1-2):1-16. doi: 10.1016/j.jim.2004.06.002. J Immunol Methods. 2004. PMID: 15251407
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: devanarayan v. 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.
Report on the AAPS Immunogenicity Guidance Forum.
Myler H, Gorovits B, Phillips K, Devanarayan V, Clements-Egan A, Gunn GR, Kirshner S, DeSilva B, Shah VP. Myler H, et al. Among authors: devanarayan v. AAPS J. 2019 Apr 16;21(4):55. doi: 10.1208/s12248-019-0328-8. AAPS J. 2019. PMID: 30993501
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. Among authors: devanarayan v. Nat Biotechnol. 2015 Apr;33(4):334-6. doi: 10.1038/nbt.3181. Nat Biotechnol. 2015. PMID: 25850051 No abstract available.
Fit-for-purpose method development and validation for successful biomarker measurement.
Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA. Lee JW, et al. Among authors: devanarayan v. Pharm Res. 2006 Feb;23(2):312-28. doi: 10.1007/s11095-005-9045-3. Epub 2006 Jan 12. Pharm Res. 2006. PMID: 16397743
76 results