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82,284 results

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Page 1
Implementing dried blood spot sampling for clinical pharmacokinetic determinations: considerations from the IQ Consortium Microsampling Working Group.
Evans C, Arnold M, Bryan P, Duggan J, James CA, Li W, Lowes S, Matassa L, Olah T, Timmerman P, Wang X, Wickremsinhe E, Williams J, Woolf E, Zane P. Evans C, et al. Among authors: li w. AAPS J. 2015 Mar;17(2):292-300. doi: 10.1208/s12248-014-9695-3. Epub 2014 Dec 9. AAPS J. 2015. PMID: 25488054 Free PMC article. No abstract available.
2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
Garofolo F, Rocci ML Jr, Dumont I, Martinez S, Lowes S, Woolf E, van Amsterdam P, Bansal S, Barra AC, Bauer R, Booth BP, Carrasco-Triguero M, DeSilva B, Dunn J, Gallicano K, Gouty D, Ho S, Hucker R, Jemal M, Katori N, Le Blaye O, Lee J, Li W, Michael S, Nehls C, Nicholson R, Ormsby E, Tang D, Viswanathan CT, Weiner R, Young G. Garofolo F, et al. Among authors: li w. Bioanalysis. 2011 Sep;3(18):2081-96. doi: 10.4155/bio.11.192. Bioanalysis. 2011. PMID: 21942519
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: li w. 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: li w. Bioanalysis. 2016 Nov;8(22):2363-2378. doi: 10.4155/bio-2016-4992. Epub 2016 Oct 7. Bioanalysis. 2016. PMID: 27712081
The effectiveness of quality control samples in pharmaceutical bioanalysis.
Keller S, Quiroz J, Christopher D, Wickremsinhe E, Geng W, Hawthorne G, James C, Katterle Y, Li W, Liu G, Mayer A, Paton M, Pav J, Potter J, Vergis J, Wang J, Westcott-Baker L, Woolf E, Xue Y. Keller S, et al. Among authors: li w. Bioanalysis. 2021 Feb;13(3):135-145. doi: 10.4155/bio-2020-0265. Epub 2021 Feb 4. Bioanalysis. 2021. PMID: 33538614
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: li w. Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17. Bioanalysis. 2017. PMID: 29148835
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Neubert H, Alley SC, Lee A, Jian W, Buonarati M, Edmison A, Garofolo F, Gorovits B, Haidar S, Mylott B, Nouri P, Qian M, Vinter S, Voelker T, Welink J, Wu J, Yang E, Yu H, Evans C, Summerfield S, Wang J, Bateman K, Boer J, Dean B, Dillen L, Faustino P, Ferrari L, Hughes N, Luo L, Olah T, Post N, Spellman DS, Sydor J, Zhang H, Zhang J, Zhang J, Fandozzi C, Wilson A, Fraier D, Beaver CJ, Dandamudi S, Dasgupta A, Elliott R, Ji A, Li W, McGuinness M, Lima Santos GM, Mirza T, Savoie N, Shakleya D, Sporring S, Stojdl S, Sundman P, Tampal N, Woolf E. Neubert H, et al. Among authors: li w. Bioanalysis. 2021 Feb;13(4):203-238. doi: 10.4155/bio-2020-0324. Epub 2021 Jan 20. Bioanalysis. 2021. PMID: 33470871
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