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Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.
Babiskin A, Wu F, Mousa Y, Tan ML, Tsakalozou E, Walenga RL, Yoon M, Raney SG, Polli JE, Schwendeman A, Krishnan V, Fang L, Zhao L. Babiskin A, et al. Among authors: yoon m. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):619-623. doi: 10.1002/psp4.12920. Epub 2023 Feb 5. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36631942 Free PMC article. Review.
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.
Gong Y, Zhang P, Yoon M, Zhu H, Kohojkar A, Hooker AC, Ducharme MP, Gobburu J, Cellière G, Gajjar P, Li BV, Velagapudi R, Tsang YC, Schwendeman A, Polli J, Fang L, Lionberger R, Zhao L. Gong Y, et al. Among authors: yoon m. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):624-630. doi: 10.1002/psp4.12931. Epub 2023 Feb 9. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36710372 Free PMC article. Review.
Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial.
Florian J, Matta MK, DePalma R, Gershuny V, Patel V, Hsiao CH, Zusterzeel R, Rouse R, Prentice K, Nalepinski CG, Kim I, Yi S, Zhao L, Yoon M, Selaya S, Keire D, Korvick J, Strauss DG. Florian J, et al. Among authors: yoon m. JAMA. 2021 Jul 20;326(3):240-249. doi: 10.1001/jama.2021.9199. JAMA. 2021. PMID: 34180947 Free PMC article. Clinical Trial.
A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms.
Hsieh NH, Bois FY, Tsakalozou E, Ni Z, Yoon M, Sun W, Klein M, Reisfeld B, Chiu WA. Hsieh NH, et al. Among authors: yoon m. J Pharmacokinet Pharmacodyn. 2021 Dec;48(6):893-908. doi: 10.1007/s10928-021-09778-5. Epub 2021 Sep 22. J Pharmacokinet Pharmacodyn. 2021. PMID: 34553275 Free PMC article.
2,249 results