Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation

Search Page

Filters

My Custom Filters

Publication date

Text availability

Article attribute

Article type

Additional filters

Article Language

Species

Sex

Age

Other

Search Results

8 results

Filters applied: . Clear all
Results are displayed in a computed author sort order. The Publication Date timeline is not available.
Page 1
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.
Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam R, Verbois L, Ghosh D, Wilson W, Duan J, Sarker H, Miksinski SP, Skarupa L, Ibrahim A, Justice R, Murgo A, Pazdur R. Thornton K, et al. Among authors: miksinski sp. Clin Cancer Res. 2012 Jul 15;18(14):3722-30. doi: 10.1158/1078-0432.CCR-12-0411. Epub 2012 Jun 4. Clin Cancer Res. 2012. PMID: 22665903 Clinical Trial.
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. Amiri-Kordestani L, et al. Among authors: miksinski sp. Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30. Clin Cancer Res. 2014. PMID: 24879797 Clinical Trial.
FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Kim G, McKee AE, Ning YM, Hazarika M, Theoret M, Johnson JR, Xu QC, Tang S, Sridhara R, Jiang X, He K, Roscoe D, McGuinn WD, Helms WS, Russell AM, Miksinski SP, Zirkelbach JF, Earp J, Liu Q, Ibrahim A, Justice R, Pazdur R. Kim G, et al. Among authors: miksinski sp. Clin Cancer Res. 2014 Oct 1;20(19):4994-5000. doi: 10.1158/1078-0432.CCR-14-0776. Epub 2014 Aug 5. Clin Cancer Res. 2014. PMID: 25096067 Review.
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu LX, Baker J, Berlam SC, Boam A, Brandreth EJ, Buhse L, Cosgrove T, Doleski D, Ensor L, Famulare J, Ganapathy M, Grampp G, Hussong D, Iser R, Johnston G, Kesisoglou F, Khan M, Kozlowski S, Lacana E, Lee SL, Miller S, Miksinski SP, Moore CM, Mullin T, Raju GK, Raw A, Rosencrance S, Rosolowsky M, Stinavage P, Thomas H, Wesdyk R, Windisch J, Vaithiyalingam S. Yu LX, et al. Among authors: miksinski sp. AAPS J. 2015 Jul;17(4):1011-8. doi: 10.1208/s12248-015-9754-4. Epub 2015 Apr 4. AAPS J. 2015. PMID: 25840884 Free PMC article.
Examining Manufacturing Readiness for Breakthrough Drug Development.
Dye E, Sturgess A, Maheshwari G, May K, Ruegger C, Ramesh U, Tan H, Cockerill K, Groskoph J, Lacana E, Lee S, Miksinski SP. Dye E, et al. Among authors: miksinski sp. AAPS PharmSciTech. 2016 Jun;17(3):529-38. doi: 10.1208/s12249-015-0455-1. Epub 2015 Nov 25. AAPS PharmSciTech. 2016. PMID: 26608693 Review. No abstract available.