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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bower J, Zimmer J, McCown S, Tabler E, Karnik S, Kar S, Sales K, Vance J, Barry C, Keyhani A, Williams D, Lester T, Garofolo F, Satterwhite C, Groeber E, Renfrew H, Lin J, Cape S, O'Dell M, Fang X, Brant A, Garofolo W, Savoie N, Hayes R, Simchik S, Sun R, Bravo O, Dufield D, Luna M, Xu A, Kane C, Farley E, Sanghvi M, Hays A, Lowes S, Islam R, Hoffpauir B, Beaver C, Dong K, Desai-Krieger D. Bower J, et al. Among authors: desai krieger d. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160 Free article.
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Fluhler E, Hayes R, Garofolo F, Dumont I, Blaye OL, Arnold M, Bansal S, Verhaeghe T, Wilson A, Stevenson L, Myler H, Bauer R, Bergeron A, Bustard M, Cai XY, Carbone M, Cojocaru L, Desai-Krieger D, Duggan J, Haidar S, Ho S, Ingelse B, Katori N, Lévesque A, Lowes S, Ma M, Mettke K, Michon J, Musuku A, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Spooner N, Stouffer B, Vazvaei F, Wakelin-Smith J, Wang J, Welink J, Whale E, Woolf E, Xue L, Yang TY. Fluhler E, et al. Among authors: desai krieger d. Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265. Bioanalysis. 2014. PMID: 25496256 Free article.
Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product.
Eichenbaum G, Johnson M, Kirkland D, O'Neill P, Stellar S, Bielawne J, DeWire R, Areia D, Bryant S, Weiner S, Desai-Krieger D, Guzzie-Peck P, Evans DC, Tonelli A. Eichenbaum G, et al. Among authors: desai krieger d. Regul Toxicol Pharmacol. 2009 Oct;55(1):33-42. doi: 10.1016/j.yrtph.2009.05.018. Epub 2009 Jun 14. Regul Toxicol Pharmacol. 2009. PMID: 19500632 Review.
Disposition, metabolism, and excretion of [14C]doripenem after a single 500-milligram intravenous infusion in healthy men.
Cirillo I, Mannens G, Janssen C, Vermeir M, Cuyckens F, Desai-Krieger D, Vaccaro N, Kao LM, Devineni D, Redman R, Turner K. Cirillo I, et al. Among authors: desai krieger d. Antimicrob Agents Chemother. 2008 Oct;52(10):3478-83. doi: 10.1128/AAC.00424-08. Epub 2008 Jul 21. Antimicrob Agents Chemother. 2008. PMID: 18644951 Free PMC article. Clinical Trial.
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