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FDALabel for drug repurposing studies and beyond.
Fang H, Harris S, Liu Z, Thakkar S, Yang J, Ingle T, Xu J, Lesko L, Rosario L, Tong W. Fang H, et al. Among authors: lesko l. Nat Biotechnol. 2020 Dec;38(12):1378-1379. doi: 10.1038/s41587-020-00751-0. Nat Biotechnol. 2020. PMID: 33235392 No abstract available.
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I. Goodsaid FM, et al. Among authors: lesko l. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 Review.
Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop.
Bai JP, Bell R, Buckman S, Burckart GJ, Eichler HG, Fang KC, Goodsaid FM, Jusko WJ, Lesko LL, Meibohm B, Patterson SD, Puig O, Smerage JB, Snider BJ, Wagner JA, Wang J, Walton MK, Weiner R. Bai JP, et al. Among authors: lesko ll. AAPS J. 2011 Jun;13(2):274-83. doi: 10.1208/s12248-011-9265-x. Epub 2011 Mar 30. AAPS J. 2011. PMID: 21448748 Free PMC article.
Reflections on Model-Informed Drug Development.
Lesko LJ, van der Graaf PH. Lesko LJ, et al. Clin Pharmacol Ther. 2024 Aug;116(2):267-270. doi: 10.1002/cpt.3335. Clin Pharmacol Ther. 2024. PMID: 39012331 No abstract available.
Exploring the impact of CYP2D6 and UGT2B7 gene-drug interactions, and CYP-mediated DDI on oxycodone and oxymorphone pharmacokinetics using physiologically-based pharmacokinetic modeling and simulation.
Klose M, Cristofoletti R, Silva CM, Mangal N, Turgeon J, Michaud V, Lesko LJ, Schmidt S. Klose M, et al. Among authors: lesko lj. Eur J Pharm Sci. 2024 Mar 1;194:106689. doi: 10.1016/j.ejps.2023.106689. Epub 2024 Jan 1. Eur J Pharm Sci. 2024. PMID: 38171419 Free article.
Identification of Novel and Early Biomarkers for Cisplatin-induced Nephrotoxicity and the Nephroprotective Role of Cimetidine using a Pharmacometabolomic-based Approach Coupled with In Vitro Toxicodynamic Modeling and Simulation.
Mody H, Nair S, Rump A, Vaidya TR, Garrett TJ, Lesko L, Ait-Oudhia S. Mody H, et al. Among authors: lesko l. J Pharm Sci. 2024 Jan;113(1):268-277. doi: 10.1016/j.xphs.2023.11.018. Epub 2023 Nov 20. J Pharm Sci. 2024. PMID: 37992870 Free article.
Fabrication and In Vitro Characterization of Novel Hydroxyapatite Scaffolds 3D Printed Using Polyvinyl Alcohol as a Thermoplastic Binder.
Thurzo A, Gálfiová P, Nováková ZV, Polák Š, Varga I, Strunga M, Urban R, Surovková J, Leško Ľ, Hajdúchová Z, Feranc J, Janek M, Danišovič Ľ. Thurzo A, et al. Among authors: lesko l. Int J Mol Sci. 2022 Nov 28;23(23):14870. doi: 10.3390/ijms232314870. Int J Mol Sci. 2022. PMID: 36499194 Free PMC article.
261 results