| Title | Bioequivalence study of risperidone F.C. 6 mg/tablet and risperdal F.C. 6 mg/tablet in healthy volunteers: appearance of somnolence in an increased percentage of volunteers because of the guideline order | |
| Authors | Chrisovaladou Tsoukia¹, Konstantinos Alexandropoulos³, Maria Kounoukla¹, 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, Psychiatric Department, Athens, Greece |
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| Citation | Tsoukia, Ch., Alexandropoulos, K., Kounoukla, M., Karagiannides, N., Koupparis, M.: Bioequivalence study of risperidone F.C. 6 mg/tablet and risperdal F.C 6 mg/tablet in healthy volunteers: appearance of somnolence in an increased percentage of volunteers because of the guideline order, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 344-346 (2006) | |
| Publication Date | Accepted for publication: 19-20 May 2006 | |
| Full Text Language | English | |
| Order – Buy | Ηλεκτρονική Μορφή: pdf (10 €) – Digital Type: pdf (10 €)
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| Keywords | Risperidone determination, antipsychotic drug, central nervous system. | |
| Other Terms | review article | |
| Summary | An efficient liquid chromatographic method with ultraviolet detection, using clozapine as internal standard, is described for the determination of antipsychotic Risperidone at 6 mg/tab in healthy volunteers. The high value of Risperidone concentration led to somnolence events in a certain number of volunteers. | |
| References | 1. Physician’s Desk Reference (PDR), 2001, Edition 55, http://www.pdr.net
2. 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) 3. 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) 4. Shen Y.L., et al.: Simultaneous determination of clozapine, clozapine N-oxide, N-desmethylclozapine, risperidone and 9- hydrohyrisperidone in plasma by high-performance liquid chromatographic with UV detection. Analytica Chemica Acta 460: 201-208 (2002) 5. Livingston M.G.: Risperidone. Lancet 343: 457-460 (1994) |
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| Relative Papers |
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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