Τόμος 20 (2006) – Τεύχος 2 – Άρθρο 50 – Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Διεθνής Έκδοση – Volume 20 (2006) – Issue 2 – Article 50 – Epitheorese Klinikes Farmakologias και Farmakokinetikes-International Edition

Title Evaluation of the bioequivalence of two pravastatin products in tablets (40 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

Citation Karatza, E., Tsoukia, Ch., Pagoni, S., Kounoukla, M., Kouris, S. et al: Evaluation of the bioequivalence of two pravastatin products in tablets (40 mg/tab) in healthy volunteers, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 201-203 (2006)
Publication Date Accepted for publication: 19-20 May 2006
Full Text Language English
Order – Buy  Ηλεκτρονική Μορφή: pdf (10 €) – Digital Type: pdf (10 €)

pharmakonpress[at]pharmakonpress[.]gr

Keywords Pravastatin determination, atilipemic agent, hydroxy-pravastatin.
Other Terms review article
Summary An efficient liquid chromatographic method with ultraviolet detection, using clobazam as internal standard is described for the determination of antilipemic agent Pravastatin in healthy volunteers. The two preparations of Pravastatin could be considered bioequivalent, regarding the ranges of values of the pharmacokinetic parameters for Pravastatin and its active metabolite Hydroxy-Pravastatin.
References 1. Pan H., Triscari J., Devault A., et al.: Pharmacokinetic Interaction between propanolol and the HMG-CoA reductase inhibitors pravastatin and lovastatin. Br. J. Clin. Pharmacol. 31: 665-670 (1991)

2. Iacona I., Regazzi B., Buggia I., et al,: High Performance Liquid Chromatography determination of Pravastatin in plasma. Therapeutic Drug Monitoring 16: 191-195 (1994)

3. Sigurbjornsson S., Kjartansdottir T., Johannsson M., et al.: A pharmacokinetic evaluation of pravastatin in middle-aged and elderly volunteers. Eur. J. Drug Metab. Pharmacokinet. 23: 13- 18 (1998)

4. Pan H., Devault A., Wang-Iverson D., et al.: Comparative pharmacokinetics and pharmacodynamics of Pravastatin and Lovastatin. J. Clin. Pharmacol. 30: 1128-1135 (1990)

5. Otter K., Mignat C., et al.: Determination of pravastatin in human plasma by high performance liquid chromatography with ultraviolet detection. J. Chromatogr. B 708: 235-241 (1998)

6. Tiller P.R., et al.: Fast LC/MS in the analysis of small molecules. Analyt. Bioanalyt. Chem. 377, 5: 788-802 (2003)

7. Miao X.S., et al.: Determination of cholesterol-lowering statin drugs in aqueous samples using liquid chromatography-electrospray ionization tandem mass spectrometry. J. Chromatogr. A 998: 133-141 (2003)

8. Garcia M.J. et al.: Clinical pharmacokinetics of statins. Meth. Finf. Exp. Clin. Pharmacol. 26,6: 457-481 (2003)

9. 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)

10. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the linear mode: An alternative to least square means. American Statistician 34: 216-221 (1980)

Relative Papers

Online ISSN 1011-6575

Άρθρα Δημοσιευμένα σε αυτό το Περιοδικό Καταχωρούνται στα:

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

Τι είναι η Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Διεθνής Έκδοση-Οδηγίες προς τους Συγγραφείς – 
What is Epitheorese Klinikes Farmakologias 
και Farmakokinetikes-International Edition-Instrunctions to Authors

Άρθρα Δημοσιευμένα στην Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Διεθνής Έκδοση – 
Articles Published in Epitheorese Klinikes Farmakologias 
και Farmakokinetikes-International Edition

Συντακτικη Επιτροπή-Editorial Board

ΕΤΗΣΙΑ ΣΥΝΔΡΟΜΗ 2006 – ANNUAL SUBSCRIPTION 2006
Γλώσσα Πλήρους Κειμένου – Full Text Language Αγγλικά – English
Παραγγελία – Αγορά – Order – Buy Ηλεκτρονική Μορφή: pdf (70 €) – Digital Type: pdf (70 €)

pharmakonpress[at]pharmakonpress[.]gr

Έντυπη Μορφή (70 € + έξοδα αποστολής) – Printed Type (70 € + shipping)

pharmakonpress[at]pharmakonpress[.]gr

 

 

 

 

Bookmark the permalink.

Comments are closed.