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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
Translating pharmacology models effectively to predict therapeutic benefit.
Dudal S, Bissantz C, Caruso A, David-Pierson P, Driessen W, Koller E, Krippendorff BF, Lechmann M, Olivares-Morales A, Paehler A, Rynn C, Türck D, Van De Vyver A, Wang K, Winther L. Dudal S, et al. Drug Discov Today. 2022 Jun;27(6):1604-1621. doi: 10.1016/j.drudis.2022.03.009. Epub 2022 Mar 15. Drug Discov Today. 2022. PMID: 35304340 Free article. Review.
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
A Novel Carcinoembryonic Antigen T-Cell Bispecific Antibody (CEA TCB) for the Treatment of Solid Tumors.
Bacac M, Fauti T, Sam J, Colombetti S, Weinzierl T, Ouaret D, Bodmer W, Lehmann S, Hofer T, Hosse RJ, Moessner E, Ast O, Bruenker P, Grau-Richards S, Schaller T, Seidl A, Gerdes C, Perro M, Nicolini V, Steinhoff N, Dudal S, Neumann S, von Hirschheydt T, Jaeger C, Saro J, Karanikas V, Klein C, Umaña P. Bacac M, et al. Among authors: dudal s. Clin Cancer Res. 2016 Jul 1;22(13):3286-97. doi: 10.1158/1078-0432.CCR-15-1696. Epub 2016 Feb 9. Clin Cancer Res. 2016. PMID: 26861458
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