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.
Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30.
Bioanalysis. 2019.
PMID: 31565956