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Page 1
The US regulatory and pharmacopeia response to the global heparin contamination crisis.
Szajek AY, Chess E, Johansen K, Gratzl G, Gray E, Keire D, Linhardt RJ, Liu J, Morris T, Mulloy B, Nasr M, Shriver Z, Torralba P, Viskov C, Williams R, Woodcock J, Workman W, Al-Hakim A. Szajek AY, et al. Among authors: woodcock j. Nat Biotechnol. 2016 Jun 9;34(6):625-30. doi: 10.1038/nbt.3606. Nat Biotechnol. 2016. PMID: 27281424 Free PMC article.
Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events.
Guerrini M, Beccati D, Shriver Z, Naggi A, Viswanathan K, Bisio A, Capila I, Lansing JC, Guglieri S, Fraser B, Al-Hakim A, Gunay NS, Zhang Z, Robinson L, Buhse L, Nasr M, Woodcock J, Langer R, Venkataraman G, Linhardt RJ, Casu B, Torri G, Sasisekharan R. Guerrini M, et al. Among authors: woodcock j. Nat Biotechnol. 2008 Jun;26(6):669-75. doi: 10.1038/nbt1407. Epub 2008 Apr 23. Nat Biotechnol. 2008. PMID: 18437154 Free PMC article.
Contaminated heparin associated with adverse clinical events and activation of the contact system.
Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K, Lansing JC, Sriranganathan N, Zhao G, Galcheva-Gargova Z, Al-Hakim A, Bailey GS, Fraser B, Roy S, Rogers-Cotrone T, Buhse L, Whary M, Fox J, Nasr M, Dal Pan GJ, Shriver Z, Langer RS, Venkataraman G, Austen KF, Woodcock J, Sasisekharan R. Kishimoto TK, et al. Among authors: woodcock j. N Engl J Med. 2008 Jun 5;358(23):2457-67. doi: 10.1056/NEJMoa0803200. Epub 2008 Apr 23. N Engl J Med. 2008. PMID: 18434646 Free PMC article.
A regulatory perspective on in vitro diagnostics.
Gottlieb S, Woodcock J. Gottlieb S, et al. Among authors: woodcock j. Nat Biotechnol. 2006 Aug;24(8):927-9. doi: 10.1038/nbt0806-927. Nat Biotechnol. 2006. PMID: 16900132 No abstract available.
Empowering microarrays in the regulatory setting.
Casciano DA, Woodcock J. Casciano DA, et al. Among authors: woodcock j. Nat Biotechnol. 2006 Sep;24(9):1103. doi: 10.1038/nbt0906-1103. Nat Biotechnol. 2006. PMID: 16964221 No abstract available.
523 results