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Page 1
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: joyce p. Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30. Bioanalysis. 2019. PMID: 31565956
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Islam R, Briscoe C, Bower J, Cape S, Arnold M, Hayes R, Warren M, Karnik S, Stouffer B, Xiao YQ, van der Strate B, Sikkema D, Fang X, Tudoroniu A, Tayyem R, Brant A, Spriggs F, Barry C, Khan M, Keyhani A, Zimmer J, Caturla MC, Couerbe P, Khadang A, Bourdage J, Datin J, Zemo J, Hughes N, Fatmi S, Sheldon C, Fountain S, Satterwhite C, Colletti K, Vija J, Yu M, Stamatopoulos J, Lin J, Wilfahrt J, Dinan A, Ohorodnik S, Hulse J, Patel V, Garofolo W, Savoie N, Brown M, Papac D, Buonarati M, Hristopoulos G, Beaver C, Boudreau N, Williard C, Liu Y, Ray G, Warrino D, Xu A, Green R, Hayward-Sewell J, Marcelletti J, Sanchez C, Kennedy M, Charles JS, Bouhajib M, Nehls C, Tabler E, Tu J, Joyce P, Iordachescu A, DuBey I, Lindsay J, Yamashita J, Wells E. Islam R, et al. Among authors: joyce p. Bioanalysis. 2018 Apr 1;10(7):433-444. doi: 10.4155/bio-2018-0014. Epub 2018 Apr 27. Bioanalysis. 2018. PMID: 29701066
Overcoming interference with the detection of a stable isotopically labeled microtracer in the evaluation of beclabuvir absolute bioavailability using a concomitant microtracer approach.
Jiang H, Titsch C, Zeng J, Jones B, Joyce P, Gandhi Y, Turley W, Burrell R, Aubry AF, Arnold ME. Jiang H, et al. Among authors: joyce p. J Pharm Biomed Anal. 2017 Sep 5;143:9-16. doi: 10.1016/j.jpba.2017.04.030. Epub 2017 May 17. J Pharm Biomed Anal. 2017. PMID: 28544885
Metproxybicyclone, a Novel Carbocyclic Aryl-dione Acetyl-CoA Carboxylase-Inhibiting Herbicide for the Management of Sensitive and Resistant Grass Weeds.
Scutt JN, Willetts NJ, Fernandes Campos B, Oliver S, Hennessy A, Joyce PM, Hutchings SJ, le Goupil G, Linares Colombo W, Kaundun SS. Scutt JN, et al. Among authors: joyce pm. J Agric Food Chem. 2024 Oct 2;72(39):21380-21392. doi: 10.1021/acs.jafc.4c02729. Epub 2024 Sep 23. J Agric Food Chem. 2024. PMID: 39311764
A translational framework to DELIVER nanomedicines to the clinic.
Joyce P, Allen CJ, Alonso MJ, Ashford M, Bradbury MS, Germain M, Kavallaris M, Langer R, Lammers T, Peracchia MT, Popat A, Prestidge CA, Rijcken CJF, Sarmento B, Schmid RB, Schroeder A, Subramaniam S, Thorn CR, Whitehead KA, Zhao CX, Santos HA. Joyce P, et al. Nat Nanotechnol. 2024 Sep 6. doi: 10.1038/s41565-024-01754-7. Online ahead of print. Nat Nanotechnol. 2024. PMID: 39242807 Review.
667 results