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9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Hayes R, LeLacheur R, Dumont I, Couerbe P, Safavi A, Islam R, Pattison C, Cape S, Rocci M, Briscoe C, Cojocaru L, Groeber E, Silvestro L, Bravo J, Shoup R, Verville M, Zimmer J, Caturla MC, Khadang A, Bourdage J, Hughes N, Fatmi S, Di Donato L, Sheldon C, Keyhani A, Satterwhite C, Yu M, Fiscella M, Hulse J, Lin ZJ, Garofolo W, Savoie N, Xiao YQ, Kurylak K, Harris S, Saxena M, Buonarati M, Lévesque A, Boudreau N, Lin J, Khan MU, Ray G, Liu Y, Xu A, Soni G, Ward I, Kingsley C, Ritzén H, Tabler E, Nicholson B, Bennett P, van de Merbel N, Karnik S, Bouhajib M, Wieling J, Mulvana D, Ingelse B, Allen M, Malone M, Fang X. Hayes R, et al. Bioanalysis. 2016 Mar;8(6):487-95. doi: 10.4155/bio.16.16. Epub 2016 Feb 26. Bioanalysis. 2016. PMID: 26916197 Free article.
A high-performance liquid chromatography-tandem mass spectrometry method for the determination of artemether and dihydroartemisinin in human plasma.
Hilhorst MJ, Hendriks G, de Vries R, Hillewaert V, Verhaege T, van de Merbel NC. Hilhorst MJ, et al. Among authors: van de merbel nc, de vries r. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Aug 15;965:45-53. doi: 10.1016/j.jchromb.2014.06.006. Epub 2014 Jun 18. J Chromatogr B Analyt Technol Biomed Life Sci. 2014. PMID: 24996069
69 results