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Consideration of a Credibility Assessment Framework in Model-Informed Drug Development: Potential Application to Physiologically-Based Pharmacokinetic Modeling and Simulation.
Kuemmel C, Yang Y, Zhang X, Florian J, Zhu H, Tegenge M, Huang SM, Wang Y, Morrison T, Zineh I. Kuemmel C, et al. Among authors: yang y. CPT Pharmacometrics Syst Pharmacol. 2020 Jan;9(1):21-28. doi: 10.1002/psp4.12479. Epub 2019 Nov 10. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 31652029 Free PMC article.
FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Casey D, Demko S, Sinha A, Mishra-Kalyani PS, Shen YL, Khasar S, Goheer MA, Helms WS, Pan L, Xu Y, Fan J, Leong R, Liu J, Yang Y, Windsor K, Ou M, Stephens O, Oh B, Reaman GH, Nair A, Shord SS, Bhatnagar V, Daniels SR, Sickafuse S, Goldberg KB, Theoret MR, Pazdur R, Singh H. Casey D, et al. Among authors: yang y. Clin Cancer Res. 2021 Aug 1;27(15):4142-4146. doi: 10.1158/1078-0432.CCR-20-5032. Epub 2021 Mar 12. Clin Cancer Res. 2021. PMID: 33712511
Model-Informed Drug Development in Pediatric Dose Selection.
Bi Y, Liu J, Li F, Yu J, Bhattaram A, Bewernitz M, Li RJ, Ahn J, Earp J, Ma L, Zhuang L, Yang Y, Zhang X, Zhu H, Wang Y. Bi Y, et al. Among authors: yang y. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S60-S69. doi: 10.1002/jcph.1848. J Clin Pharmacol. 2021. PMID: 34185906 Review.
Anti-SARS-CoV-2 Repurposing Drug Database: Clinical Pharmacology Considerations.
Zhang X, Yang Y, Grimstein M, Liu G, Kitabi E, Fan J, Wang YH, Earp J, Weaver JL, Zhu H, Liu J, Reynolds KS, Huang SM, Wang Y. Zhang X, et al. Among authors: yang y. CPT Pharmacometrics Syst Pharmacol. 2021 Sep;10(9):973-982. doi: 10.1002/psp4.12681. Epub 2021 Aug 1. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34218521 Free PMC article. Review.
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.
Jean D, Naik K, Milligan L, Hall S, Mei Huang S, Isoherranen N, Kuemmel C, Seo P, Tegenge MA, Wang Y, Yang Y, Zhang X, Zhao L, Zhao P, Benjamin J, Bergman K, Grillo J, Madabushi R, Wu F, Zhu H, Zineh I. Jean D, et al. Among authors: yang y. CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1271-1275. doi: 10.1002/psp4.12706. Epub 2021 Sep 18. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34536337 Free PMC article. No abstract available.
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