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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).
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: welink j. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782 Free article.
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. Among authors: welink j. Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164. Bioanalysis. 2010. PMID: 21110739 Free article.
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, Yang E. DeSilva B, et al. Among authors: welink j. Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205. Bioanalysis. 2012. PMID: 23046264 Free article.
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.
Stevenson L, Garofolo F, DeSilva B, Dumont I, Martinez S, Rocci M, Amaravadi L, Brudny-Kloeppel M, Musuku A, Booth B, Dicaire C, Wright L, Mayrand-Provencher L, Losauro M, Gouty D, Arnold M, Bansal S, Dudal S, Dufield D, Duggan J, Evans C, Fluhler E, Fraser S, Gorovits B, Haidar S, Hayes R, Ho S, Houghton R, Islam R, Jenkins R, Katori N, Kaur S, Kelley M, Knutsson M, Lee J, Liu H, Lowes S, Ma M, Mikulskis A, Myler H, Nicholson B, Olah T, Ormsby E, Patel S, Pucci V, Ray C, Schultz G, Shih J, Shoup R, Simon C, Song A, Neto JT, Theobald V, Thway T, Wakelin-Smith J, Wang J, Wang L, Welink J, Whale E, Woolf E, Xu R. Stevenson L, et al. Among authors: welink j. Bioanalysis. 2013 Dec;5(23):2903-18. doi: 10.4155/bio.13.238. Epub 2013 Oct 10. Bioanalysis. 2013. PMID: 24107004 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: welink j. Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265. Bioanalysis. 2014. PMID: 25496256 Free article.
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: welink j. Bioanalysis. 2014;6(23):3237-49. doi: 10.4155/bio.14.279. Bioanalysis. 2014. PMID: 25529890 Free article.
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. Bioanalysis. 2015;7(22):2913-25. doi: 10.4155/bio.15.204. Epub 2015 Nov 17. Bioanalysis. 2015. PMID: 26573485 Free article.
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: welink j. Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2. Bioanalysis. 2015. PMID: 26627049 Free article.
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: welink j. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247 Free article.
41 results