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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: dudal s. Bioanalysis. 2013 Dec;5(23):2903-18. doi: 10.4155/bio.13.238. Epub 2013 Oct 10. Bioanalysis. 2013. PMID: 24107004 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: dudal s. Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205. Bioanalysis. 2012. PMID: 23046264 Free article.
Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.
Booth B, Arnold ME, DeSilva B, Amaravadi L, Dudal S, Fluhler E, Gorovits B, Haidar SH, Kadavil J, Lowes S, Nicholson R, Rock M, Skelly M, Stevenson L, Subramaniam S, Weiner R, Woolf E. Booth B, et al. Among authors: dudal s. AAPS J. 2015 Mar;17(2):277-88. doi: 10.1208/s12248-014-9696-2. Epub 2014 Dec 31. AAPS J. 2015. PMID: 25549614 Free PMC article.
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.
Kelley M, Stevenson L, Golob M, Devanarayan V, Pedras-Vasconcelos J, Staack RF, Jenkins R, Booth B, Wakshull E, Bowsher R, Rock M, Dudal S, DeSilva B. Kelley M, et al. Among authors: dudal s. AAPS J. 2015 Jul;17(4):1019-24. doi: 10.1208/s12248-015-9767-z. Epub 2015 Apr 30. AAPS J. 2015. PMID: 25921938 Free PMC article.
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Leach MW, Clarke DO, Dudal S, Han C, Li C, Yang Z, Brennan FR, Bailey WJ, Chen Y, Deslandes A, Loberg LI, Mayawala K, Rogge MC, Todd M, Chemuturi NV. Leach MW, et al. Among authors: dudal s. Clin Pharmacol Ther. 2021 Jun;109(6):1395-1415. doi: 10.1002/cpt.2009. Epub 2020 Nov 3. Clin Pharmacol Ther. 2021. PMID: 32757299
Toward in vitro-to-in vivo translation of monoclonal antibody pharmacokinetics: Application of a neonatal Fc receptor-mediated transcytosis assay to understand the interplaying clearance mechanisms.
Jaramillo CAC, Belli S, Cascais AC, Dudal S, Edelmann MR, Haak M, Brun ME, Otteneder MB, Ullah M, Funk C, Schuler F, Simon S. Jaramillo CAC, et al. Among authors: dudal s. MAbs. 2017 Jul;9(5):781-791. doi: 10.1080/19420862.2017.1320008. Epub 2017 Apr 25. MAbs. 2017. PMID: 28440708 Free PMC article.
28 results