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Addressing Today's Absorption, Distribution, Metabolism, and Excretion (ADME) Challenges in the Translation of In Vitro ADME Characteristics to Humans: A Case Study of the SMN2 mRNA Splicing Modifier Risdiplam.
Fowler S, Brink A, Cleary Y, Günther A, Heinig K, Husser C, Kletzl H, Kratochwil N, Mueller L, Savage M, Stillhart C, Tuerck D, Ullah M, Umehara K, Poirier A. Fowler S, et al. Among authors: cleary y. Drug Metab Dispos. 2022 Jan;50(1):65-75. doi: 10.1124/dmd.121.000563. Epub 2021 Oct 7. Drug Metab Dispos. 2022. PMID: 34620695 Review.
A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a SMN2 splicing modifier.
Sturm S, Günther A, Jaber B, Jordan P, Al Kotbi N, Parkar N, Cleary Y, Frances N, Bergauer T, Heinig K, Kletzl H, Marquet A, Ratni H, Poirier A, Müller L, Czech C, Khwaja O. Sturm S, et al. Among authors: cleary y. Br J Clin Pharmacol. 2019 Jan;85(1):181-193. doi: 10.1111/bcp.13786. Epub 2018 Nov 16. Br J Clin Pharmacol. 2019. PMID: 30302786 Free PMC article. Clinical Trial.
Development of a physiologically based pharmacokinetic model for mefloquine and its application alongside a clinical effectiveness model to select an optimal dose for prevention of malaria in young Caucasian children.
Johnson TN, Cleary Y, Parrott N, Reigner B, Smith JR, Toovey S. Johnson TN, et al. Among authors: cleary y. Br J Clin Pharmacol. 2019 Jan;85(1):100-113. doi: 10.1111/bcp.13764. Epub 2018 Nov 5. Br J Clin Pharmacol. 2019. PMID: 30198595 Free PMC article.
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib.
Morcos PN, Cleary Y, Sturm-Pellanda C, Guerini E, Abt M, Donzelli M, Vazvaei F, Balas B, Parrott N, Yu L. Morcos PN, et al. Among authors: cleary y. J Clin Pharmacol. 2018 Dec;58(12):1618-1628. doi: 10.1002/jcph.1286. Epub 2018 Jul 27. J Clin Pharmacol. 2018. PMID: 30052269 Free PMC article.
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M. Shebley M, et al. Among authors: cleary y. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29315504 Free PMC article. Review.
17 results