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Brief Report

Effect of X-ray radiation exposure on lyophilized recombinant activated factor VII (formulated for storage at room temperature)

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Pages 2699-2702 | Accepted 01 Sep 2009, Published online: 23 Sep 2009

References

  • Nedergaard H, Vestergaard S, Jensen PT, et al. In vitro stability of lyophilized and reconstituted recombinant activated factor VII formulated for storage at room temperature. Clin Ther 2008;30:1309-15
  • Jurlander B, Thim L, Klausen NK, et al. Recombinant activated factor VII (rFVIIa): characterization, manufacturing, and clinical development. Semin Thromb Hemost 2001;27:373-84
  • Schulman S, Bech Jensen M, Varon D, et al. Feasibility of using recombinant factor VIIa in continuous infusion. Thromb Haemost 1996;75:432-6
  • Kornfelt T, Persson E, Palm L. Oxidation of methionine residues in coagulation factor VIIa. Arch Biochem Biophys 1999;363:43-54
  • Mollerup I, Bayne S, Halkjaer E, et al. The use of RP-HPLC for measuring activation and cleavage of rFVIIa during purification. Biotech Bioeng 1995;48:501-5
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Topic Q2(R1): Validation of analytical procedures: Text and methodology. ICH, 2005. Available at: http://www.ich.org/cache/compo/363-272-1.html#Q2A [Last accessed 1 July 2009]

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