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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
Schanberg LE, Mulugeta LY, Akinlade B, Brunner HI, Chen J, Colbert RA, Delgaizo V, Gastonguay MR, Glaser R, Imundo L, Lovell DJ, Leu JH, Mostafa NM, Nelson RM, Nigrovic PA, Nikolov NP, Rider LG, Rothwell R, Sahajwalla C, Singh R, Sinha V, Yancey CL, Yao L. Schanberg LE, et al. Among authors: yao l. Arthritis Rheumatol. 2023 Oct;75(10):1856-1866. doi: 10.1002/art.42534. Epub 2023 Aug 3. Arthritis Rheumatol. 2023. PMID: 37067688
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ. Mulugeta Y, et al. Among authors: yao l. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.
Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, Bucci-Rechtweg C, Burckart GJ, Chambers CD, Hale TW, Johnson-Lyles D, Nelson RM, Nguyen C, Pica-Branco D, Ren Z, Sachs H, Sauberan J, Zajicek A, Ito S, Yao LP. Wang J, et al. Among authors: yao lp. Clin Pharmacol Ther. 2017 Jun;101(6):736-744. doi: 10.1002/cpt.676. Clin Pharmacol Ther. 2017. PMID: 28510297 Free PMC article. Review.
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Fleming TR, Garnett CE, Conklin LS, Corriol-Rohou S, Hariharan S, Hsu D, Mueller-Velten G, Mulugeta Y, Portman R, Rothmann MD, Stockbridge NL, Wandel S, Zhang J, Yao L. Fleming TR, et al. Among authors: yao l. Ther Innov Regul Sci. 2023 Jan;57(1):109-120. doi: 10.1007/s43441-022-00445-6. Epub 2022 Sep 3. Ther Innov Regul Sci. 2023. PMID: 36057747 Free PMC article.
8,898 results