Grillo J - Search Results

1

U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia.

Lee HZ, Miller BW, Kwitkowski VE, Ricci S, DelValle P, Saber H, Grillo J, Bullock J, Florian J, Mehrotra N, Ko CW, Nie L, Shapiro M, Tolnay M, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. Lee HZ, et al. Among authors: grillo j. Clin Cancer Res. 2014 Aug 1;20(15):3902-7. doi: 10.1158/1078-0432.CCR-14-0516. Epub 2014 May 13. Clin Cancer Res. 2014. PMID: 24824310 Clinical Trial.

2

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.

Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM. Zhao P, et al. Among authors: grillo ja. Clin Pharmacol Ther. 2011 Feb;89(2):259-67. doi: 10.1038/clpt.2010.298. Epub 2010 Dec 29. Clin Pharmacol Ther. 2011. PMID: 21191381

3

Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.

Grillo JA, Zhao P, Bullock J, Booth BP, Lu M, Robie-Suh K, Berglund EG, Pang KS, Rahman A, Zhang L, Lesko LJ, Huang SM. Grillo JA, et al. Biopharm Drug Dispos. 2012 Mar;33(2):99-110. doi: 10.1002/bdd.1771. Epub 2012 Mar 4. Biopharm Drug Dispos. 2012. PMID: 22270945

4

U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.

Deisseroth A, Kaminskas E, Grillo J, Chen W, Saber H, Lu HL, Rothmann MD, Brar S, Wang J, Garnett C, Bullock J, Burke LB, Rahman A, Sridhara R, Farrell A, Pazdur R. Deisseroth A, et al. Among authors: grillo j. Clin Cancer Res. 2012 Jun 15;18(12):3212-7. doi: 10.1158/1078-0432.CCR-12-0653. Epub 2012 Apr 27. Clin Cancer Res. 2012. PMID: 22544377

5

U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia.

Alvandi F, Kwitkowski VE, Ko CW, Rothmann MD, Ricci S, Saber H, Ghosh D, Brown J, Pfeiler E, Chikhale E, Grillo J, Bullock J, Kane R, Kaminskas E, Farrell AT, Pazdur R. Alvandi F, et al. Among authors: grillo j. Oncologist. 2014 Jan;19(1):94-9. doi: 10.1634/theoncologist.2013-0077. Epub 2013 Dec 5. Oncologist. 2014. PMID: 24309980 Free PMC article.

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. Clin Pharmacokinet. 2015 Jan;54(1):117-27. doi: 10.1007/s40262-014-0188-4. Clin Pharmacokinet. 2015. PMID: 25260695

7

Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

Schuck RN, Grillo JA. Schuck RN, et al. AAPS J. 2016 May;18(3):573-7. doi: 10.1208/s12248-016-9891-4. Epub 2016 Feb 24. AAPS J. 2016. PMID: 26912182 Free PMC article. Review.

8

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. Among authors: grillo j. 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

9

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: grillo ja. J Clin Pharmacol. 2020 Oct;60 Suppl 1:S160-S178. doi: 10.1002/jcph.1767. J Clin Pharmacol. 2020. PMID: 33205429

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. 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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