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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: savoie n. Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2. Bioanalysis. 2015. PMID: 26627049
2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Savoie N, Garofolo F, van Amsterdam P, Bansal S, Beaver C, Bedford P, Booth BP, Evans C, Jemal M, Lefebvre M, Lopes de Silva AL, Lowes S, Marini JC, Massé R, Mawer L, Ormsby E, Rocci ML Jr, Viswanathan C, Wakelin-Smith J, Welink J, White JT, Woolf E. Savoie N, et al. Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164. Bioanalysis. 2010. PMID: 21110739
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: savoie n. Bioanalysis. 2015;7(22):2913-25. doi: 10.4155/bio.15.204. Epub 2015 Nov 17. Bioanalysis. 2015. PMID: 26573485
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J. Amaravadi L, et al. Among authors: savoie n. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247
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: savoie n. 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: savoie n. Bioanalysis. 2016 Dec;8(23):2457-2474. doi: 10.4155/bio-2016-4988. Bioanalysis. 2016. PMID: 27855509
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: savoie n. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512
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: savoie n. 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: savoie n. Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205053
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. Gupta S, et al. Among authors: savoie n. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064
42 results