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Review of the Technical, Toxicological, and PKPD Considerations for Conducting Inhalation Toxicity Studies on Biologic Pharmaceuticals-The Outcome of a Cross-Industry Working Group Survey.
Wolfreys A, Kilgour J, Allen AD, Dudal S, Freke M, Jones D, Karantabias G, Krantz C, Moore S, Mukaratirwa S, Price M, Tepper J, Cauvin A, Manetz S, Robinson I. Wolfreys A, et al. Among authors: dudal s. Toxicol Pathol. 2021 Feb;49(2):261-285. doi: 10.1177/0192623321988841. Epub 2021 Feb 3. Toxicol Pathol. 2021. PMID: 33535023 Review.
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.
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
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.
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
28 results