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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: barrett yc. 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: barrett yc. 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.
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: barrett yc. Pharm Res. 2006 Feb;23(2):312-28. doi: 10.1007/s11095-005-9045-3. Epub 2006 Jan 12. Pharm Res. 2006. PMID: 16397743
Prospective testing for drug-dependent antibodies reduces the incidence of thrombocytopenia observed with the small molecule glycoprotein IIb/IIIa antagonist roxifiban: implications for the etiology of thrombocytopenia.
Seiffert D, Stern AM, Ebling W, Rossi RJ, Barrett YC, Wynn R, Hollis GF, He B, Kieras CJ, Pedicord DL, Cromley DA, Hua TA, Stein RB, Daly RN, Sferruzza A, Pieniaszek HJ, Billheimer JT. Seiffert D, et al. Among authors: barrett yc. Blood. 2003 Jan 1;101(1):58-63. doi: 10.1182/blood-2002-02-0471. Epub 2002 Jun 28. Blood. 2003. PMID: 12393571 Free article. Clinical Trial.
Identification and validation of phospho-SRC, a novel and potential pharmacodynamic biomarker for dasatinib (SPRYCEL), a multi-targeted kinase inhibitor.
Luo FR, Barrett YC, Yang Z, Camuso A, McGlinchey K, Wen ML, Smykla R, Fager K, Wild R, Palme H, Galbraith S, Blackwood-Chirchir A, Lee FY. Luo FR, et al. Among authors: barrett yc. Cancer Chemother Pharmacol. 2008 Nov;62(6):1065-74. doi: 10.1007/s00280-008-0699-5. Epub 2008 Feb 27. Cancer Chemother Pharmacol. 2008. PMID: 18301894 Free article.
27 results