Kozlowski S - Search Results

1

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: kozlowski s. 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.

2

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.

3

Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars.

Ghasriani H, Hodgson DJ, Brinson RG, McEwen I, Buhse LF, Kozlowski S, Marino JP, Aubin Y, Keire DA. Ghasriani H, et al. Among authors: kozlowski s. Nat Biotechnol. 2016 Feb;34(2):139-41. doi: 10.1038/nbt.3474. Nat Biotechnol. 2016. PMID: 26849514 Free PMC article. No abstract available.

4

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.

5

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.

6

An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.

Fisher AC, Liu W, Schick A, Ramanadham M, Chatterjee S, Brykman R, Lee SL, Kozlowski S, Boam AB, Tsinontides SC, Kopcha M. Fisher AC, et al. Among authors: kozlowski s. Int J Pharm. 2022 Jun 25;622:121778. doi: 10.1016/j.ijpharm.2022.121778. Epub 2022 Apr 29. Int J Pharm. 2022. PMID: 35500688 Free article.

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

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.

9

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

10

Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.

McMahon AW, Pratt RG, Hammad TA, Kozlowski S, Zhou E, Lu S, Kulick CG, Mallick T, Dal Pan G. McMahon AW, et al. Among authors: kozlowski s. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):921-33. doi: 10.1002/pds.1991. Pharmacoepidemiol Drug Saf. 2010. PMID: 20661880

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