Comparison of two RP-HPLC methods for determination of recombinant human thrombin in pharmaceutical formulations. / Porovnanie dvoch RP-HPLC metód pre stanovenie rekombinantného ľudského trombínu vo farmaceutických formuláciách

[1] Chang JY. The structures and proteolytic specificities of autolysed human thrombin. Biochem J. 1986; 15;240(3):797-802.10.1042/bj2400797Search in Google Scholar

[2] Chapman WC, Singla N, Genyk Y, McNeil J W, Renkens K L Jr, Reynolds T C, Murphy A, Weaver F A. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007; 205(2):256-265.10.1016/j.jamcollsurg.2007.03.020Search in Google Scholar

[3] Cheng CH M, Meyer-Massetti C, Kayser S R. A review of three stand-alone topical Thrombin for surgical hemostasis. Clin Ther. 2009;31(1):32-41.10.1016/j.clinthera.2009.01.005Search in Google Scholar

[4] Geng X, Regnier FE. Retention Model for Proteins in Reversed- Phase Liquid Chromatography, J Chrom. 1984;296:15-30.10.1016/S0021-9673(01)96399-XSearch in Google Scholar

[5] Karlsson G. Analysis of human alpha-thrombin by hydrophobic interaction high-performance liquid chromatography. Protein Expr Purif. 2003;27(1):171-4.10.1016/S1046-5928(02)00596-XSearch in Google Scholar

[6] Lew WK, Weaver F A. Clinical use of topical thrombin as a surgical hepostat. Biologics 2008; 2(4):593-599.Search in Google Scholar

[7] Manning, MC, Chou DK, Murphy BM, Payne RW, Katayama DS.Stability of Protein Pharmaceuticals: An update. Pharm Res.2010; 27(4):544-575.10.1007/s11095-009-0045-6Search in Google Scholar

[8] Ortel TL, Mercel MC, Thames EH, Moore KD, Lawson JH. Immunologic Impact and Clinical Outcomes After Surgical Exposure to Bovine Thrombin. Ann Surg. 2001;233(1):88-96.10.1097/00000658-200101000-00014Search in Google Scholar

[9] Patro SY, Freud E, Chang BS. Protein formulation and fill-finish operations. Biotechnol Annu Rev. 2002; 8:55-84.10.1016/S1387-2656(02)08004-3Search in Google Scholar

[10] Regan F, Taylor C. Blood transfusion medicine. Br Med J. 2002; 325:143-147.10.1136/bmj.325.7356.143112367212130612Search in Google Scholar