Kozlowski S - Search Results

1

Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices.

Rosenberg AS, Cherney B, Brorson K, Clouse K, Kozlowski S, Hughes P, Friedman R. Rosenberg AS, et al. Among authors: kozlowski s. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):563-7. doi: 10.5731/pdajpst.2011.00820. PDA J Pharm Sci Technol. 2011. PMID: 22294578

2

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. Carpenter JF, et al. Among authors: kozlowski s. J Pharm Sci. 2009 Apr;98(4):1201-5. doi: 10.1002/jps.21530. J Pharm Sci. 2009. PMID: 18704929 Free PMC article. No abstract available.

3

Hurdles and leaps for protein therapeutics.

Kozlowski S, Cherney B, Donnelly RP. Kozlowski S, et al. Ann N Y Acad Sci. 2009 Dec;1182:146-60. doi: 10.1111/j.1749-6632.2009.05158.x. Ann N Y Acad Sci. 2009. PMID: 20074283

4

The FDA's assessment of follow-on protein products: a historical perspective.

Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, Hixon D, Joneckis C, Kozlowski S, Rosenberg A, Schrager L, Shacter E, Temple R, Webber K, Winkle H. Woodcock J, et al. Among authors: kozlowski s. Nat Rev Drug Discov. 2007 Jun;6(6):437-42. doi: 10.1038/nrd2307. Nat Rev Drug Discov. 2007. PMID: 17633790 Review.

5

The isolated major histocompatibility complex class I alpha3 domain binds beta2m and CD8alphaalpha dimers.

Whitman MC, Strohmaier J, O'Boyle K, Tingem JM, Wilkinson Y, Goldstein J, Chen T, Brorson K, Brunswick M, Kozlowski S. Whitman MC, et al. Among authors: kozlowski s. Mol Immunol. 2000 Feb-Mar;37(3-4):141-9. doi: 10.1016/s0161-5890(00)00034-1. Mol Immunol. 2000. PMID: 10865113

6

Biosimilars: considerations for an abbreviated pathway.

Kozlowski S, Behrman R. Kozlowski S, et al. Leuk Lymphoma. 2009 Apr;50(4):527-8. doi: 10.1080/10428190902853151. Leuk Lymphoma. 2009. PMID: 19373649 No abstract available.

7

Current and future issues in the manufacturing and development of monoclonal antibodies.

Kozlowski S, Swann P. Kozlowski S, et al. Adv Drug Deliv Rev. 2006 Aug 7;58(5-6):707-22. doi: 10.1016/j.addr.2006.05.002. Epub 2006 May 22. Adv Drug Deliv Rev. 2006. PMID: 16828921 Review.

8

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

Fisher AC, Lee SL, Harris DP, Buhse L, Kozlowski S, Yu L, Kopcha M, Woodcock J. Fisher AC, et al. Among authors: kozlowski s. Int J Pharm. 2016 Dec 30;515(1-2):390-402. doi: 10.1016/j.ijpharm.2016.10.038. Epub 2016 Oct 20. Int J Pharm. 2016. PMID: 27773853 Review.

9

Biosimilars: The US Regulatory Framework.

Christl LA, Woodcock J, Kozlowski S. Christl LA, et al. Among authors: kozlowski s. Annu Rev Med. 2017 Jan 14;68:243-254. doi: 10.1146/annurev-med-051215-031022. Epub 2016 Oct 28. Annu Rev Med. 2017. PMID: 27813877 Review.

10

Developing the nation's biosimilars program.

Kozlowski S, Woodcock J, Midthun K, Sherman RB. Kozlowski S, et al. N Engl J Med. 2011 Aug 4;365(5):385-8. doi: 10.1056/NEJMp1107285. N Engl J Med. 2011. PMID: 21812668 No abstract available.

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