Grimstein M - Search Results

1

Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy.

Leong R, Grimstein M, DeMaria P, Norsworthy KJ, Fletcher EP, Shord S. Leong R, et al. Among authors: grimstein m. J Clin Pharmacol. 2023 Jun;63 Suppl 1:S170-S175. doi: 10.1002/jcph.2224. J Clin Pharmacol. 2023. PMID: 37317488

2

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

3

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 Free PMC article.

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

5

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

6

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

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

Physiologically Based Pharmacokinetics Modeling in the Neonatal Population-Current Advances, Challenges, and Opportunities.

Dinh J, Johnson TN, Grimstein M, Lewis T. Dinh J, et al. Among authors: grimstein m. Pharmaceutics. 2023 Nov 3;15(11):2579. doi: 10.3390/pharmaceutics15112579. Pharmaceutics. 2023. PMID: 38004559 Free PMC article. Review.

10

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.

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