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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.
Bioanalysis. 2019.
PMID: 31833782
Free article.
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: blaye ol.
Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265.
Bioanalysis. 2014.
PMID: 25496256
Free article.
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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Welink J, Fluhler E, Hughes N, Arnold M, Garofolo F, Bustard M, Coppola L, Dhodda R, Evans C, Gleason C, Haidar S, Hayes R, Heinig K, Katori N, Blaye OL, Li W, Liu G, Lima Santos GM, Meng M, Nicholson B, Savoie N, Skelly M, Sojo L, Tampal N, de Merbel Nv, Verhaeghe T, Vinter S, Wickremsinhe E, Whale E, Wilson A, Witte B, Woolf E.
Welink J, et al. Among authors: blaye ol.
Bioanalysis. 2015;7(22):2913-25. doi: 10.4155/bio.15.204. Epub 2015 Nov 17.
Bioanalysis. 2015.
PMID: 26573485
Free article.
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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Welink J, Yang E, Hughes N, Rago B, Woolf E, Sydor J, Coppola L, Ackermann B, Li W, Alley SC, Arnold M, Berger I, Briscoe C, Buonarati M, Bustard M, Cancilla M, Cho SJ, Duggan J, Fraier D, Garofolo F, Green R, Haidar S, Hittle L, Ishii-Watabe A, Islam R, Jenkins R, Jones B, Kadavil J, Kassim S, Kavetska O, Blaye OL, Lee A, Liu H, Mehl J, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Surapaneni S, Szapacs M, Tampal N, Verhaeghe T, Vinter S, Whale E.
Welink J, et al. Among authors: blaye ol.
Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17.
Bioanalysis. 2017.
PMID: 29148835
Free article.
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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Neubert H, Song A, Lee A, Wei C, Duggan J, Xu K, Woolf E, Evans C, Palandra J, Laterza O, Amur S, Berger I, Bustard M, Cancilla M, Chen SC, Cho SJ, Ciccimaro E, Cludts I, Cocea L, D'Arienzo C, Danan-Leon L, Donato LD, Garofolo F, Haidar S, Ishii-Watabe A, Jiang H, Kadavil J, Kassim S, Kurki P, Blaye OL, Liu K, Mathews R, Lima Santos GM, Niwa M, Pedras-Vasconcelos J, Qian M, Rago B, Saad O, Saito Y, Savoie N, Su D, Szapacs M, Tampal N, Vinter S, Wang J, Welink J, Whale E, Wilson A, Xue YJ.
Neubert H, et al. Among authors: blaye ol.
Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5.
Bioanalysis. 2017.
PMID: 29205053
Free article.
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Variations in internal standard response: some thoughts and real-life cases.
Blaye OL.
Blaye OL.
Bioanalysis. 2019 Sep;11(18):1715-1725. doi: 10.4155/bio-2019-0146. Epub 2019 Sep 26.
Bioanalysis. 2019.
PMID: 31556317
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