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Items: 10

1.

Considerations for Biologic Product Drug-Drug Interactions: A Regulatory Perspective.

Schrieber SJ, Pfuma-Fletcher E, Wang X, Wang YC, Sagoo S, Madabushi R, Huang SM, Zineh I.

Clin Pharmacol Ther. 2019 Jun;105(6):1332-1334. doi: 10.1002/cpt.1366. Epub 2019 Mar 7. No abstract available.

PMID:
30844077
2.

Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.

Wang YC, Wang Y, Schrieber SJ, Earp J, Thway TM, Huang SM, Zineh I, Christl L.

J Pharm Sci. 2019 Jan;108(1):73-77. doi: 10.1016/j.xphs.2018.10.053. Epub 2018 Nov 3.

PMID:
30395832
3.

FDA's Approval of the First Biosimilar to Bevacizumab.

Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

PMID:
29743182
4.

Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients.

Li L, Ma L, Schrieber SJ, Rahman NA, Deisseroth A, Farrell AT, Wang Y, Sinha V, Marathe A.

Clin Pharmacol Ther. 2018 Oct;104(4):742-748. doi: 10.1002/cpt.991. Epub 2018 Feb 2.

PMID:
29392707
5.

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.

Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R.

Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27.

6.

FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.

Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30.

7.

Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C.

Schrieber SJ, Hawke RL, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Meyers CM, Doo E, Fried MW.

Drug Metab Dispos. 2011 Dec;39(12):2182-90. doi: 10.1124/dmd.111.040212. Epub 2011 Aug 24.

8.

Silymarin ascending multiple oral dosing phase I study in noncirrhotic patients with chronic hepatitis C.

Hawke RL, Schrieber SJ, Soule TA, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Berman J, Liu QY, Doo E, Fried MW; SyNCH Trial Group.

J Clin Pharmacol. 2010 Apr;50(4):434-49. doi: 10.1177/0091270009347475. Epub 2009 Oct 19.

9.

The pharmacokinetics of silymarin is altered in patients with hepatitis C virus and nonalcoholic Fatty liver disease and correlates with plasma caspase-3/7 activity.

Schrieber SJ, Wen Z, Vourvahis M, Smith PC, Fried MW, Kashuba AD, Hawke RL.

Drug Metab Dispos. 2008 Sep;36(9):1909-16. doi: 10.1124/dmd.107.019604. Epub 2008 Jun 19.

PMID:
18566043
10.

Pharmacokinetics and metabolic profile of free, conjugated, and total silymarin flavonolignans in human plasma after oral administration of milk thistle extract.

Wen Z, Dumas TE, Schrieber SJ, Hawke RL, Fried MW, Smith PC.

Drug Metab Dispos. 2008 Jan;36(1):65-72. Epub 2007 Oct 3.

PMID:
17913795

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