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Page 1
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Fluhler E, Hayes R, Garofolo F, Dumont I, Blaye OL, Arnold M, Bansal S, Verhaeghe T, Wilson A, Stevenson L, Myler H, Bauer R, Bergeron A, Bustard M, Cai XY, Carbone M, Cojocaru L, Desai-Krieger D, Duggan J, Haidar S, Ho S, Ingelse B, Katori N, Lévesque A, Lowes S, Ma M, Mettke K, Michon J, Musuku A, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Spooner N, Stouffer B, Vazvaei F, Wakelin-Smith J, Wang J, Welink J, Whale E, Woolf E, Xue L, Yang TY. Fluhler E, et al. Among authors: cai xy. Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265. Bioanalysis. 2014. PMID: 25496256
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F, Alley SC, Thway T, Joyce A, Bansal S, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Dumont I, Fluhler E, Fraser S, Gouty D, Gupta S, Haidar S, Hayes R, Ingelse B, Ishii-Watabe A, Kaur S, King L, Laterza O, Leung S, Lévesque A, Ma M, Petit-Frere C, Pillutla R, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wakelin-Smith J, Wilson A, Woolf E, Yang TY. Stevenson L, et al. Among authors: cai xy. Bioanalysis. 2014;6(24):3355-68. doi: 10.4155/bio.14.283. Bioanalysis. 2014. PMID: 25534792
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).
Dufield D, Neubert H, Garofolo F, Kirkovsky L, Stevenson L, Dumont I, Kaur S, Xu K, Alley SC, Szapacs M, Arnold M, Bansal S, Haidar S, Welink J, Le Blaye O, Wakelin-Smith J, Whale E, Ishii-Watabe A, Bustard M, Katori N, Amaravadi L, Aubry AF, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Duggan J, Fluhler E, Gorovits B, Gupta S, Hayes R, Ho S, Ingelse B, King L, Lévesque A, Lowes S, Ma M, Musuku A, Myler H, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wilson A, Woolf E, Xue L, Yang TY. Dufield D, et al. Among authors: cai xy. Bioanalysis. 2014;6(23):3237-49. doi: 10.4155/bio.14.279. Bioanalysis. 2014. PMID: 25529890
Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. Marini JC, et al. Among authors: cai xy. AAPS J. 2014 Nov;16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3. AAPS J. 2014. PMID: 25277165 Free PMC article.
382 results