Grimstein M - Search Results

1

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: grimstein m. 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.

2

A regulatory science viewpoint on botanical-drug interactions.

Grimstein M, Huang SM. Grimstein M, et al. J Food Drug Anal. 2018 Apr;26(2S):S12-S25. doi: 10.1016/j.jfda.2018.01.013. Epub 2018 Feb 15. J Food Drug Anal. 2018. PMID: 29703380 Free PMC article. Review.

3

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology.

Grimstein M, Yang Y, Zhang X, Grillo J, Huang SM, Zineh I, Wang Y. Grimstein M, et al. J Pharm Sci. 2019 Jan;108(1):21-25. doi: 10.1016/j.xphs.2018.10.033. Epub 2018 Oct 29. J Pharm Sci. 2019. PMID: 30385284

4

Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology.

Zhang X, Yang Y, Grimstein M, Fan J, Grillo JA, Huang SM, Zhu H, Wang Y. Zhang X, et al. Among authors: grimstein m. J Clin Pharmacol. 2020 Oct;60 Suppl 1:S160-S178. doi: 10.1002/jcph.1767. J Clin Pharmacol. 2020. PMID: 33205429

5

Usage of In Vitro Metabolism Data for Drug-Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug Administration.

Lee J, Yang Y, Zhang X, Fan J, Grimstein M, Zhu H, Wang Y. Lee J, et al. Among authors: grimstein m. J Clin Pharmacol. 2021 Jun;61(6):782-788. doi: 10.1002/jcph.1819. Epub 2021 Feb 9. J Clin Pharmacol. 2021. PMID: 33460193

6

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.

Mathieu LN, Larkins E, Akinboro O, Roy P, Amatya AK, Fiero MH, Mishra-Kalyani PS, Helms WS, Myers CE, Skinner AM, Aungst S, Jin R, Zhao H, Xia H, Zirkelbach JF, Bi Y, Li Y, Liu J, Grimstein M, Zhang X, Woods S, Reece K, Abukhdeir AM, Ghosh S, Philip R, Tang S, Goldberg KB, Pazdur R, Beaver JA, Singh H. Mathieu LN, et al. Among authors: grimstein m. Clin Cancer Res. 2022 Jan 15;28(2):249-254. doi: 10.1158/1078-0432.CCR-21-1566. Epub 2021 Aug 3. Clin Cancer Res. 2022. PMID: 34344795 Review.

7

Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction.

Fan J, Yang Y, Grimstein M, Zhang X, Kitabi E, Earp JC, Arya V, Reynolds KS, Zhu H, Wang Y. Fan J, et al. Among authors: grimstein m. Clin Pharmacol Ther. 2022 Mar;111(3):624-634. doi: 10.1002/cpt.2445. Epub 2021 Nov 8. Clin Pharmacol Ther. 2022. PMID: 34656075

8

Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.

Xiong Y, Fan J, Kitabi E, Zhang X, Bi Y, Grimstein M, Yang Y, Earp JC, Zheng N, Liu J, Wang Y, Zhu H. Xiong Y, et al. Among authors: grimstein m. Clin Pharmacol Ther. 2022 Mar;111(3):572-578. doi: 10.1002/cpt.2491. Epub 2021 Dec 4. Clin Pharmacol Ther. 2022. PMID: 34807992 Free PMC article. Review.

9

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.

Telaraja D, Kasamon YL, Collazo JS, Leong R, Wang K, Li P, Dahmane E, Yang Y, Earp J, Grimstein M, Rodriguez LR, Theoret MR, Gormley NJ. Telaraja D, et al. Among authors: grimstein m. Clin Cancer Res. 2024 Jan 5;30(1):17-22. doi: 10.1158/1078-0432.CCR-23-1272. Clin Cancer Res. 2024. PMID: 37624619

10

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: grimstein m. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S122-31. doi: 10.1002/jcph.740. J Clin Pharmacol. 2016. PMID: 27385170 Review.

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