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: bourdage j.
Bioanalysis. 2018 Apr 1;10(7):433-444. doi: 10.4155/bio-2018-0014. Epub 2018 Apr 27.
Bioanalysis. 2018.
PMID: 29701066