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Page 1
Immunoassay Methods.
Cox KL, Devanarayan V, Kriauciunas A, Manetta J, Montrose C, Sittampalam S. Cox KL, et al. Among authors: devanarayan v. 2012 May 1 [updated 2019 Jul 8]. In: Markossian S, Grossman A, Baskir H, Arkin M, Auld D, Austin C, Baell J, Brimacombe K, Chung TDY, Coussens NP, Dahlin JL, Devanarayan V, Foley TL, Glicksman M, Gorshkov K, Grotegut S, Hall MD, Hoare S, Inglese J, Iversen PW, Lal-Nag M, Li Z, Manro JR, McGee J, Norvil A, Pearson M, Riss T, Saradjian P, Sittampalam GS, Tarselli MA, Trask OJ Jr, Weidner JR, Wildey MJ, Wilson K, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–. 2012 May 1 [updated 2019 Jul 8]. In: Markossian S, Grossman A, Baskir H, Arkin M, Auld D, Austin C, Baell J, Brimacombe K, Chung TDY, Coussens NP, Dahlin JL, Devanarayan V, Foley TL, Glicksman M, Gorshkov K, Grotegut S, Hall MD, Hoare S, Inglese J, Iversen PW, Lal-Nag M, Li Z, Manro JR, McGee J, Norvil A, Pearson M, Riss T, Saradjian P, Sittampalam GS, Tarselli MA, Trask OJ Jr, Weidner JR, Wildey MJ, Wilson K, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–. PMID: 22553884 Free Books & Documents. 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: 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.
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. Among authors: devanarayan v. 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.
Reporting guidelines for human microbiome research: the STORMS checklist.
Mirzayi C, Renson A; Genomic Standards Consortium; Massive Analysis and Quality Control Society; Zohra F, Elsafoury S, Geistlinger L, Kasselman LJ, Eckenrode K, van de Wijgert J, Loughman A, Marques FZ, MacIntyre DA, Arumugam M, Azhar R, Beghini F, Bergstrom K, Bhatt A, Bisanz JE, Braun J, Bravo HC, Buck GA, Bushman F, Casero D, Clarke G, Collado MC, Cotter PD, Cryan JF, Demmer RT, Devkota S, Elinav E, Escobar JS, Fettweis J, Finn RD, Fodor AA, Forslund S, Franke A, Furlanello C, Gilbert J, Grice E, Haibe-Kains B, Handley S, Herd P, Holmes S, Jacobs JP, Karstens L, Knight R, Knights D, Koren O, Kwon DS, Langille M, Lindsay B, McGovern D, McHardy AC, McWeeney S, Mueller NT, Nezi L, Olm M, Palm N, Pasolli E, Raes J, Redinbo MR, Rühlemann M, Balfour Sartor R, Schloss PD, Schriml L, Segal E, Shardell M, Sharpton T, Smirnova E, Sokol H, Sonnenburg JL, Srinivasan S, Thingholm LB, Turnbaugh PJ, Upadhyay V, Walls RL, Wilmes P, Yamada T, Zeller G, Zhang M, Zhao N, Zhao L, Bao W, Culhane A, Devanarayan V, Dopazo J, Fan X, Fischer M, Jones W, Kusko R, Mason CE, Mercer TR, Sansone SA, Scherer A, Shi L, Thakkar S, Tong W, Wolfinger R, Hunter C, Segata N, Huttenhower C, Dowd JB, Jones HE… See abstract for full author list ➔ Mirzayi C, et al. Among authors: devanarayan v. Nat Med. 2021 Nov;27(11):1885-1892. doi: 10.1038/s41591-021-01552-x. Epub 2021 Nov 17. Nat Med. 2021. PMID: 34789871 Free PMC article. Review.
HTS Assay Validation.
Iversen PW, Beck B, Chen YF, Dere W, Devanarayan V, Eastwood BJ, Farmen MW, Iturria SJ, Montrose C, Moore RA, Weidner JR, Sittampalam GS. Iversen PW, et al. Among authors: devanarayan v. 2012 May 1 [updated 2012 Oct 1]. In: Markossian S, Grossman A, Baskir H, Arkin M, Auld D, Austin C, Baell J, Brimacombe K, Chung TDY, Coussens NP, Dahlin JL, Devanarayan V, Foley TL, Glicksman M, Gorshkov K, Grotegut S, Hall MD, Hoare S, Inglese J, Iversen PW, Lal-Nag M, Li Z, Manro JR, McGee J, Norvil A, Pearson M, Riss T, Saradjian P, Sittampalam GS, Tarselli MA, Trask OJ Jr, Weidner JR, Wildey MJ, Wilson K, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–. 2012 May 1 [updated 2012 Oct 1]. In: Markossian S, Grossman A, Baskir H, Arkin M, Auld D, Austin C, Baell J, Brimacombe K, Chung TDY, Coussens NP, Dahlin JL, Devanarayan V, Foley TL, Glicksman M, Gorshkov K, Grotegut S, Hall MD, Hoare S, Inglese J, Iversen PW, Lal-Nag M, Li Z, Manro JR, McGee J, Norvil A, Pearson M, Riss T, Saradjian P, Sittampalam GS, Tarselli MA, Trask OJ Jr, Weidner JR, Wildey MJ, Wilson K, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–. PMID: 22553862 Free Books & Documents. Review.
The impact of real-world evidence in implementing and optimizing Alzheimer's disease care.
Hampel H, Li G, Mielke MM, Galvin JE, Kivipelto M, Santarnecchi E, Babiloni C, Devanarayan V, Tkatch R, Hu Y, Kurzman R, Cho M, Vandercappellen J, Nakamura Y, Bell J, Mattke S, Toschi N. Hampel H, et al. Among authors: devanarayan v. Med. 2025 May 9;6(5):100695. doi: 10.1016/j.medj.2025.100695. Med. 2025. PMID: 40347934 Free article. Review.
85 results