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270 L. VLASE, D. MUNTEAN, A. POPA, M. NEAG, I. BÂLDEA, M. ACHIM, S. E. LEUCUŢA The elimination rate constant kel was estimated by the least-square regression of plasma concentration-time data points lying in the terminal region by using semilogarithmic dependence that corresponds to a first-order kinetics. The half-life (t½) was calculated as 0.693/kel. The absorption constant rate of ivabradine (ka) was calculated using a mono-compartmental pharmacokinetic model by fitting the data using the equation: Q = D k a ka − k el ( e −kelt − e −kat where Q is the quantity of ivabradine in the body at time “t” after oral administration, D is the doze and ka and kel are the absorption and elimination rate constants in hr −1 . The pharmacokinetic analysis was performed using Kinetica 4.0.2 (Thermo Labsystems, U.S.A.) [13]. Statistical analysis The t-test for paired values was used to compare the calculated pharmacokinetic parameters of ivabradine for the two periods. In order to evaluate a possible clinical significance of the pharmacokinetic interaction, an analysis of variance (ANOVA) was performed on the pharmacokinetic parameters Cmax and AUC0-∞ using general linear model procedures, in which sources of variation were subject and period. Then the 90% confidence intervals of the test/reference period ratios for Cmax and AUC0-∞ (log transformed) were determined by the Schuirmann’s two one-sided t test [14]. The bioequivalence between ivabradine in Test and Reference period can be concluded when the 90% confidence intervals for these pharmacokinetic parameters of two products are found within an acceptable range of 0.8- 1.25 [15-18]. Regarding analysis of tmax, the limit for bioequivalence range was expressed as untransformed data, the significance of the difference of tmax (Test-Reference) being established by a nonparametric test (Friedman test). All the statistical analysis was performed using Kinetica 4.0.2 software [13]. ACKNOWLEDGMENTS This work was supported by a PNII-IDEI project, code 462, contract 229/2007 financed by CNCSIS Romania, for which the authors gratefully acknowledge. )
PHARMACOKINETIC INTERACTION BETWEEN IVABRADINE AND CIPROFLOXACINE … REFERENCES 1. U.K. Prasad, D. Gray, H. Purcell, Advances In Therapy, 2009, 26(2), 127. 2. M.Z. Khawaja, D.M. Walker, International Journal Of Clinical Practice, 2009, 63(4), 542 3. J. C. Tardif, P. Ponikowski, T. Kahan, European Heart Journal, 2009, 30(5), 540 4. P. Milliez, S. Messaoudi, J. Nehme, C. Rodriguez, J. L. Samuel, C. Delcayre, American Journal Of Physiology-Heart And Circulatory Physiology, 2009, 296(2), H435 5. G. Riccioni, N. Vitulano, N. D'Orazio, Advances In Therapy, 2009, 26(1), 12 6. A. Portoles, A. Calvo, A. Terleira, L. Laredo, G. Resplandy, C. Gorostiaga, A. Moreno, Journal of Clinical Pharmacology, 2006, 46, 1195. 7. A. Portoles, A. Terleira, A. Calvo, Journal Of Clinical Pharmacology, 2006, 46(10), 1188 8. A. Portoles, A. Calvo, A. Terleira, L. Laredo, G. Resplandy, G. Gorostiaga, A. Moreno, Journal Of Clinical Pharmacology, 2006, 46(10), 1195 9. Z. Iqbal, A. Khan, A. Naz, J. A. Khan, G. S. Khan, Clinical Drug Investigation, 2009, 29(4), 275 10. H. S. Abou-Auda, A. A. Mustafa, M. S. Al-Humayyd, Biopharmaceutics & Drug Disposition, 2008, 29(1), 29 11. K. Herrlin, M. Segerdahl, L. L. Gustafsson, E. Kalso, Lancet, 2000 356(9247), 2069. 12. L. Vlase, D. Muntean, S. E. Leucuta, I. Baldea, Studia Universitatis Babes- Bolyai Chemia, 2009, 54(2), 43 13. http://www.thermo.com/eThermo/CMA/PDFs/Product/productPDF_27347.pdf 14. D. J. Schuirmann, J Pharmacokinet Biopharm 1987, 15(6), 657 15. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products – General Considerations, Rockville, USA, 2003, http://www.fda.gov/cder/guidance/index.htm 16. The European Agency for the Evaluation of Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, London, UK, 2001 (CPMP/EWP/QWP/1401/98). 17. L. Vlase, A. Leucuta, D. Farcau D, M. Nanulescu, Biopharmaceutics & Drug Disposition, 2006, 27(6), 285 18. L. Vlase, B. Bodiu B, S.E. Leucuta, Arzneimittel-Forschung-Drug Research, 2005, 55(11), 664 271
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ANA-MARIA CORMOS, JOZSEF GASPAR, AN
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Studia Universitatis Babes-Bolyai C
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6 PROFESSOR IOAN BÂLDEA AT HIS 70
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MARCELA ACHIM, DANA MUNTEAN, LAURIA
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STUDIA UNIVERSITATIS BABEŞ-BOLYAI,
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STUDIES ON WO3 THIN FILMS PREPARED
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CONCLUSIONS 148 CRISTINA MIHALI, GA
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152 D. MIHU, L. VLASE, S. IMRE, C.
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EXPERIMENTAL SECTION 210 MARIA ŞTE
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