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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: tsakalozou e. 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.
A phase I study of 7-t-butyldimethylsilyl-10-hydroxycamptothecin in adult patients with refractory or metastatic solid malignancies.
Arnold SM, Rinehart JJ, Tsakalozou E, Eckardt JR, Fields SZ, Shelton BJ, DeSimone PA, Kee BK, Moscow JA, Leggas M. Arnold SM, et al. Among authors: tsakalozou e. Clin Cancer Res. 2010 Jan 15;16(2):673-80. doi: 10.1158/1078-0432.CCR-09-2429. Epub 2010 Jan 12. Clin Cancer Res. 2010. PMID: 20068096 Free PMC article. Clinical Trial.
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.
Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, Lukacova V, Eissing T, Tsakalozou E, Zhao L, Lionberger R. Zhang X, et al. Among authors: tsakalozou e. CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):492-495. doi: 10.1002/psp4.12204. Epub 2017 Jul 11. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28571121 Free PMC article.
Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension.
Le Merdy M, Fan J, Bolger MB, Lukacova V, Spires J, Tsakalozou E, Patel V, Xu L, Stewart S, Chockalingam A, Narayanasamy S, Rouse R, Matta M, Babiskin A, Kozak D, Choi S, Zhang L, Lionberger R, Zhao L. Le Merdy M, et al. Among authors: tsakalozou e. AAPS J. 2019 May 20;21(4):65. doi: 10.1208/s12248-019-0334-x. AAPS J. 2019. PMID: 31111305
Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions.
Donnelly M, Tsakalozou E, Sharan S, Straubinger T, Bies R, Zhao L. Donnelly M, et al. Among authors: tsakalozou e. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S26-S33. doi: 10.1002/jcph.1760. J Clin Pharmacol. 2020. PMID: 33274513 Review. No abstract available.
41 results