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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Briscoe C, Hughes N, Hayes R, Islam R, Bennett P, Stouffer B, Cape S, Rhyne P, Beaver C, Charles JS, Kakkanaiah V, Xu A, Caturla MC, Spriggs F, Tayyem R, Barry C, Keyhani A, Zimmer J, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Matassa L, Garofolo W, Savoie N, Hristopoulos G, Xu A, Goodwin L, Awaiye K, Ritzén H, Bouhajib M, Marco CD, Savu SR, Nehls C, Tabler E, Hays A, Karnik S, Brown M, Lowes S, DuBey I, Kulagina N, Lindsay J, Williard C, Wang H, Malone M, Wells E, Fang X, Moussallie M. Briscoe C, et al. Among authors: matassa l. Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19. Bioanalysis. 2019. PMID: 31319683
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Nehls C, Buonarati M, Cape S, Islam R, Satterwhite C, Briscoe C, Hayes R, Dinan A, Sales K, Anderson S, Vance J, Lindsay J, Zimmer J, Couerbe P, Khadang A, Maasjo S, Bravo O, Lindley K, Moran L, Sangster T, Vija J, Stamatopoulos J, Lin J, Reuschel S, Underberg A, MacNeill R, Matassa L, Spytko A, Garofolo W, Savoie N, Rhyne P, Ambrosius J, Barra V, Dufield D, Luna M, Spriggs F, Fedorov E, Ritzén H, Fatmi S, Kane C, Bouhajib M, DiMarco C, Iordachescu A, Tudoroniu A, Farley E, Stouffer B, Tabler E, McCown S, Bower J, Harrison T, Karnik S, Brown M, Joyce P, DuBey I, Hoffpauir B, Boudreau N, Bergeron J, Wang H, Feng H, Zhou S, Wells E, Pirro J, Fang X, Shi J, Yang C. Nehls C, et al. Among authors: matassa l. Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30. Bioanalysis. 2019. PMID: 31565956
Determination of GDC-0449, a small-molecule inhibitor of the Hedgehog signaling pathway, in human plasma by solid phase extraction-liquid chromatographic-tandem mass spectrometry.
Ding X, Chou B, Graham RA, Cheeti S, Percey S, Matassa LC, Reuschel SA, Meng M, Liu S, Voelker T, Lum BL, Rudewicz PJ, Hop CE. Ding X, et al. Among authors: matassa lc. J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Mar 15;878(9-10):785-90. doi: 10.1016/j.jchromb.2010.01.039. Epub 2010 Feb 1. J Chromatogr B Analyt Technol Biomed Life Sci. 2010. PMID: 20172765
Implementing dried blood spot sampling for clinical pharmacokinetic determinations: considerations from the IQ Consortium Microsampling Working Group.
Evans C, Arnold M, Bryan P, Duggan J, James CA, Li W, Lowes S, Matassa L, Olah T, Timmerman P, Wang X, Wickremsinhe E, Williams J, Woolf E, Zane P. Evans C, et al. Among authors: matassa l. AAPS J. 2015 Mar;17(2):292-300. doi: 10.1208/s12248-014-9695-3. Epub 2014 Dec 9. AAPS J. 2015. PMID: 25488054 Free PMC article. No abstract available.