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2018 4
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Population PK Analyses of Ubrogepant (MK-1602), a CGRP Receptor Antagonist: Enriching In-Clinic Plasma PK Sampling With Outpatient Dried Blood Spot Sampling.
Li CC, Dockendorf M, Kowalski K, Yang B, Xu Y, Xie I, Kleijn HJ, Bosch R, Jones C, Thornton B, Marcantonio EE, Voss T, Bateman KP, Kothare PA. Li CC, et al. Among authors: Xie I. J Clin Pharmacol. 2018 Mar;58(3):294-303. doi: 10.1002/jcph.1021. Epub 2017 Nov 14. J Clin Pharmacol. 2018. PMID: 29136283 Clinical Trial.
Extractability-mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis.
Xie I, Xu Y, Anderson M, Wang M, Xue L, Breidinger S, Goykhman D, Woolf EJ, Bateman KP. Xie I, et al. J Pharm Biomed Anal. 2018 Jul 15;156:58-66. doi: 10.1016/j.jpba.2018.04.001. Epub 2018 Apr 5. J Pharm Biomed Anal. 2018. PMID: 29689469
Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study.
Dockendorf MF, Murthy G, Bateman KP, Kothare PA, Anderson M, Xie I, Sachs JR, Burlage R, Goldman A, Moyer M, Shah JK, Ruba R, Shipley L, Harrelson J. Dockendorf MF, et al. Among authors: Xie I. Clin Pharmacol Ther. 2019 Jan;105(1):168-176. doi: 10.1002/cpt.1142. Epub 2018 Jul 23. Clin Pharmacol Ther. 2019. PMID: 29885208 Free PMC article. Clinical Trial.
Making Better Dose Decisions: Using Exposure-Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment.
Li CC, Voss T, Kowalski K, Yang B, Kleijn HJ, Jones CJ, Bosch R, Michelson D, DeAngelis M, Xu Y, Xie I, Kothare PA. Li CC, et al. Among authors: Xie I. Clin Transl Sci. 2020 May;13(3):482-490. doi: 10.1111/cts.12730. Epub 2020 Jan 16. Clin Transl Sci. 2020. PMID: 31758661 Free PMC article.
Suitability of a minipig model in assessing clinical bioperformance of matrix and multiparticulate extended-release formulations for a BCS class III Drug development candidate.
Kesisoglou F, Xie IH, Manser K, Wu Y, Hardy I, Fitzpatrick S. Kesisoglou F, et al. Among authors: Xie IH. J Pharm Sci. 2014 Feb;103(2):636-42. doi: 10.1002/jps.23837. Epub 2013 Dec 30. J Pharm Sci. 2014. PMID: 24382706 Clinical Trial.