Validation of the anti-factor IIa assay and potency assessment of enoxaparin in pharmaceutical formulations

Farmaco

Volumn 60, Issue 3, 2005, Pages 225-229

  Dalmora, Sérgio Luiz ^a   Junior, Liberato Brum ^a   Vaccari, Silvana Ferreira ^a   Fronza, Marcio ^a   Renato De Oliveira, Paulo ^a   Rolim, Clarice Madalena Bueno ^a  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

Author keywords

Anti factor IIa; Anti factor Xa; Enoxaparin; Low molecular weight heparin; Validation

Indexed keywords

ENOXAPARIN; LOW MOLECULAR WEIGHT HEPARIN; PROTHROMBIN A; PROTHROMBIN ANTIBODY;

ACCURACY; ARTERY THROMBOSIS; ARTICLE; BIOASSAY; CONCENTRATION RESPONSE; DRUG DETERMINATION; DRUG FORMULATION; DRUG INDICATION; DRUG POTENCY; LINEAR SYSTEM; PARAMETER; QUALITY CONTROL; QUANTITATIVE ANALYSIS; QUANTUM YIELD; REPRODUCIBILITY; VALIDATION PROCESS;

EID: 15244339838     PISSN: 0014827X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.farmac.2004.12.006     Document Type: Article

References (13)

1. T.W. Barrowcliffe, and D.P. Thomas Heparin and low molecular weight heparin A.L. Bloom C.D. Forbes D.P. Thomas E.G.D. Tuddenham Haemostasis and Thrombosis, 3rd ed 1994 Churchill Livingstone New York 1417 1438
2. B. Boneu Low molecular weight heparins: are they superior to unfractionated heparins to prevent and to treat deep vein thrombosis? Thromb. Res. 100 2000 113 120
3. J. Hirsh, S.S. Anand, J.L. Halperin, and V. Fuster Mechanism of action and pharmacology of unfractionated heparin Arterioscler. Thromb. Vasc. Biol. 21 2001 1094 1096
4. J.-B. Hansen, and P.M. Sandset Differential effects of low molecular weight heparin and unfractionated heparin on circulating levels of antithrombin and tissue factor pathway inhibitor (TFPI): a possible mechanism for difference in therapeutic efficacy Thromb. Res. 91 1998 177 181
5. V.A. Rodie, A.J. Thomson, F.M. Stewart, A.J. Quinn, I.D. Walker, and I.A. Greer Low molecular weight heparin for the treatment of venous thromboembolism in pregnancy: a case series Br. J. Obstet. Gynaecol. 109 2002 1020 1024
6. M.M. Samama Synthetic direct and indirect factor Xa inhibitors Thromb. Res. 106 2002 267 273
7. T.W. Barrowcliffe Collaborative study for the establishment of low molecular mass heparins biological reference preparations Pharmeuropa 1 1996 7 22
8. D. Brieger, and J. Dawes Characterisation of persistent anti-Xa activity following administration of the low molecular weight heparin enoxaparin sodium (clexane) Thromb. Haemost. 72 1994 275 280
9. European Pharmacopoeia, 4th ed 2002 European Department for the Quality of Medicines Strasbourg
10. L. Houbouyan, A. Padilla, E. Gray, C. Longstaff, and T.W. Barrowcliffe Inhibition of thrombin generation by heparin and LMW heparins: a comparison of chromogenic and clotting methods Blood Coag. Fibrinolysis. 7 1996 24 30
11. S.L. Dalmora, L. Brum Junior, C.A. Schmidt, S.F. Vaccari, P.R. Oliveira, and C.F. Codevilla Validation of the anti-factor Xa assay for the potency assessment of enoxaparin in pharmaceutical formulation J. AOAC Int. 87 6 2004 1305 1308
12. D.J. Finney Statistical methods in biological assay 1978 Charles Griffin London
13. International Conference on Harmonisation (ICH), Validation of Analytical Procedures: Methodology, ICH Harmonised Tripartite Guideline, ICH Q2B, 6 November 1996.