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A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K. Altar CA, et al. Among authors: devanarayan v. Clin Pharmacol Ther. 2008 Feb;83(2):368-71. doi: 10.1038/sj.clpt.6100451. Epub 2007 Dec 19. Clin Pharmacol Ther. 2008. PMID: 18091762
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
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.
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.
Kelley M, Stevenson L, Golob M, Devanarayan V, Pedras-Vasconcelos J, Staack RF, Jenkins R, Booth B, Wakshull E, Bowsher R, Rock M, Dudal S, DeSilva B. Kelley M, et al. Among authors: devanarayan v. AAPS J. 2015 Jul;17(4):1019-24. doi: 10.1208/s12248-015-9767-z. Epub 2015 Apr 30. AAPS J. 2015. PMID: 25921938 Free PMC article.
78 results