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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.
Bioanalysis
; 10(7): 433-444, 2018 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29701066
2.
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bioanalysis
; 6(22): 2957-63, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25496252
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