Hsu V - Search Results

1

FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation.

Pamuk GE, Chow ECY, Ionan AC, Chen H, Lee SL, Hsu V, Grimstein M, Zheng N, Sun J, Charlab R, Gehrke BJ, Vallejo J, Ehrlich LA, de Claro RA, Theoret MR. Pamuk GE, et al. Among authors: hsu v. Clin Cancer Res. 2024 Oct 1;30(19):4266-4271. doi: 10.1158/1078-0432.CCR-24-1086. Clin Cancer Res. 2024. PMID: 39088257

2

FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.

Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, Hsu V, Li F, Ricks TK, Song P, Tang S, Waldron PE, Yu J, Zahalka E, Goldberg KB, Pazdur R, Theoret MR, Ibrahim A, Beaver JA. Chang E, et al. Among authors: hsu v. Clin Cancer Res. 2021 Feb 15;27(4):922-927. doi: 10.1158/1078-0432.CCR-20-2275. Epub 2020 Sep 22. Clin Cancer Res. 2021. PMID: 32962979

3

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.

Norsworthy KJ, Luo L, Hsu V, Gudi R, Dorff SE, Przepiorka D, Deisseroth A, Shen YL, Sheth CM, Charlab R, Williams GM, Goldberg KB, Farrell AT, Pazdur R. Norsworthy KJ, et al. Among authors: hsu v. Clin Cancer Res. 2019 Jun 1;25(11):3205-3209. doi: 10.1158/1078-0432.CCR-18-3749. Epub 2019 Jan 28. Clin Cancer Res. 2019. PMID: 30692099

4

The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.

Pan Y, Hsu V, Grimstein M, Zhang L, Arya V, Sinha V, Grillo JA, Zhao P. Pan Y, et al. Among authors: hsu v. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S122-31. doi: 10.1002/jcph.740. J Clin Pharmacol. 2016. PMID: 27385170 Review.

5

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA.

Wagner C, Pan Y, Hsu V, Sinha V, Zhao P. Wagner C, et al. Among authors: hsu v. Clin Pharmacokinet. 2016 Apr;55(4):475-83. doi: 10.1007/s40262-015-0330-y. Clin Pharmacokinet. 2016. PMID: 26369776

6

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration.

Wagner C, Pan Y, Hsu V, Grillo JA, Zhang L, Reynolds KS, Sinha V, Zhao P. Wagner C, et al. Among authors: hsu v. Clin Pharmacokinet. 2015 Jan;54(1):117-27. doi: 10.1007/s40262-014-0188-4. Clin Pharmacokinet. 2015. PMID: 25260695

7

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.

Wagner C, Zhao P, Pan Y, Hsu V, Grillo J, Huang SM, Sinha V. Wagner C, et al. Among authors: hsu v. CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17. CPT Pharmacometrics Syst Pharmacol. 2015. PMID: 26225246 Free PMC article.

8

Predictive Performance of Physiologically-Based Pharmacokinetic Models in Predicting Drug-Drug Interactions Involving Enzyme Modulation.

Hsueh CH, Hsu V, Pan Y, Zhao P. Hsueh CH, et al. Among authors: hsu v. Clin Pharmacokinet. 2018 Oct;57(10):1337-1346. doi: 10.1007/s40262-018-0635-8. Clin Pharmacokinet. 2018. PMID: 29455429

9

PBPK Modeling of the Effect of Reduced Kidney Function on the Pharmacokinetics of Drugs Excreted Renally by Organic Anion Transporters.

Hsueh CH, Hsu V, Zhao P, Zhang L, Giacomini KM, Huang SM. Hsueh CH, et al. Among authors: hsu v. Clin Pharmacol Ther. 2018 Mar;103(3):485-492. doi: 10.1002/cpt.750. Epub 2017 Jul 24. Clin Pharmacol Ther. 2018. PMID: 28738449

10

Towards quantitation of the effects of renal impairment and probenecid inhibition on kidney uptake and efflux transporters, using physiologically based pharmacokinetic modelling and simulations.

Hsu V, de L T Vieira M, Zhao P, Zhang L, Zheng JH, Nordmark A, Berglund EG, Giacomini KM, Huang SM. Hsu V, et al. Clin Pharmacokinet. 2014 Mar;53(3):283-293. doi: 10.1007/s40262-013-0117-y. Clin Pharmacokinet. 2014. PMID: 24214317 Free PMC article. Review.

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