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Page 1
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
Ackermann B, Neubert H, Hughes N, Garofolo F, Abberley L, Alley SC, Brown-Augsburger P, Bustard M, Chen LZ, Heinrich J, Katori N, Kaur S, Kirkovsky L, Laterza OF, Le Blaye O, Lévesque A, Santos GM, Olah T, Savoie N, Skelly M, Spitz S, Szapacs M, Tampal N, Wang J, Welink J, Wieling J, Haidar S, Vinter S, Whale E, Witte B. Ackermann B, et al. Among authors: vinter s. Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2. Bioanalysis. 2015. PMID: 26627049
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: vinter s. Bioanalysis. 2015;7(22):2913-25. doi: 10.4155/bio.15.204. Epub 2015 Nov 17. Bioanalysis. 2015. PMID: 26573485
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).
Yang E, Welink J, Cape S, Woolf E, Sydor J, James C, Goykhman D, Arnold M, Addock N, Bauer R, Buonarati M, Ciccimaro E, Dodda R, Evans C, Garofolo F, Hughes N, Islam R, Nehls C, Wilson A, Briscoe C, Bustard M, Coppola L, Croft S, Drexler D, Ferrari L, Fraier D, Jenkins R, Kadavil J, King L, Li W, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Sun R, Tampal N, Vinter S, Wakelin-Smith J, Yue Q. Yang E, et al. Among authors: vinter s. Bioanalysis. 2016 Nov;8(22):2363-2378. doi: 10.4155/bio-2016-4992. Epub 2016 Oct 7. Bioanalysis. 2016. PMID: 27712081
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
Song A, Lee A, Garofolo F, Kaur S, Duggan J, Evans C, Palandra J, Donato LD, Xu K, Bauer R, Bustard M, Chen L, Cocea L, Croft S, Galliccia F, Haidar S, Hughes N, Ishii-Watabe A, Islam R, Jones B, Kadavil J, Krantz C, Lima Santos GM, Olah T, Pedras-Vasconcelos J, Staelens L, Saito Y, Savoie N, Scheibner K, Spitz S, Tampal N, Thomas E, Vinter S, Wakelin-Smith J, Welink J, Zeng J, Zhou S. Song A, et al. Among authors: vinter s. Bioanalysis. 2016 Dec;8(23):2457-2474. doi: 10.4155/bio-2016-4988. Bioanalysis. 2016. PMID: 27855509
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: vinter s. Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17. Bioanalysis. 2017. PMID: 29148835
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: vinter s. Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205053
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Lima Santos GM, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel NV, Verthelyi D, Vinter S, Whale E. Welink J, et al. Among authors: vinter s. Bioanalysis. 2018 Nov 1;10(22):1781-1801. doi: 10.4155/bio-2018-0268. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488725
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S. Neubert H, et al. Among authors: vinter s. Bioanalysis. 2018 Dec;10(23):1897-1917. doi: 10.4155/bio-2018-0285. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488729 Review.
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).
Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. Booth B, et al. Among authors: vinter s. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782
29 results