| Title | Evaluation of the bioequivalence of two simvastatin products in tablets (80 mg/tab) in healthy volunteers | |
| Authors | Eleftheria Karatza¹, Chrisovaladou Tsoukia¹, Stamatia Pagoni³, Mary Kounoukla¹, Spiros Kouris¹, Maria Katsiampani¹, Dimitra Charisi¹, Nikolaos Karagiannides¹ and Michael Koupparis²
1. Mentor Laboratories S.A., Spaton Avenue 197, Pallini, Attiki, Greece 2. Laboratory of Analytical Chemistry, Department of Chemistry, University of Athens 3. General National Hospital of Athens G. Gennimatas, 3rd Internal Medicine Dept., Athens, Greece |
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| Citation | Karatza, E., Tsoukia, Ch., Pagoni, S., Kounoukla, M., Kouris, S. et al: Evaluation of the bioequivalence of two simvastatin products in tablets (80 mg/tab) in healthy volunteers, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 204-205 (2006) | |
| Publication Date | Accepted for publication: 19-20 May 2006 | |
| Full Text Language | English | |
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| Keywords | Simvastatin determination, antilipemic agent, active metabolite (simvastatin acid). | |
| Other Terms | review article | |
| Summary | An efficient liquid chromatographic method, with mass spectrometric detection, using lovastatin as internal standard is described for the determination of the antilipemic agent Simvastatin in healthy volunteers. The two preparations of Simvastatin could be considered bio- equivalent, regarding the ranges values of the pharmacokinetic parameters for Simvastatin and its active metabolite Simvastatin acid. | |
| References | 1. Tiller P.R., et al.: Fast LC/MS in the analysis of small molecules. Analyt. Bioanalyt. Chem. 377, 5: 788-802 (2003)
2. Miao X.S., et al.: Determination of cholesterol-lowering statin drugs in aqueous samples using liquid chromatography-elecionization tandem mass spectrometry. J. Chromatogr. A 998: 133-141 (2003) 3. Zhao J.J., et al.: Quantitation of simvastatin and its b-hydroxy-acid in human plasma by liquid-liquid cartridge extraction and liquid chromatography-tandem mass spectrometry. 35: 1133-1143 (2000) 4. Garcia M.J. et al.: Clinical pharmacokinetics of statins. Meth. Finf. Exp. Clin. Pharmacol. 26,6: 457-481 (2003) 5. Mauro V.F.: Clinical pharmacokinetics and practical applications of simvastatin. Clin. Pharmacokinet. 24: 195-202 (1993) 6. Najib N.M., et al.: Pharmacokinetics and bioequivalence of two simvastatin 40mg tablets in healthy human volunteers. Biopharm. Drug Disp. 24: 183-189 (2003) 7. Diletti E., Haushke D., Stenijans V.W.: Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 29: 1-8 (1993) 8. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the linear model: An alternative to least square means. American Statistician 34: 216-221 (1980) |
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Online ISSN 1011-6575
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Articles published in this Journal are Indexed or Abstracted in: • Chemical Abstracts • Elsevier’s Bibliographic Databases: Scopus, EMBASE, EMBiology, Elsevier BIOBASE SCImago Journal and Country Rank Factor
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