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Volumn 47, Issue 2, 2009, Pages 124-131

Bioequivalence evaluation of two strengths of risperidone tablet formulations in healthy volunteers

Author keywords

Bioequivalence; Healthy subjects; Pharmacokinetics; Risperidone; Tablet

Indexed keywords

CLOZAPINE; PALIPERIDONE; RISPERIDONE; 9 HYDROXY RISPERIDONE; 9-HYDROXY-RISPERIDONE; ISOXAZOLE DERIVATIVE; NEUROLEPTIC AGENT; PYRIMIDINE DERIVATIVE;

EID: 62749159078     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP47124     Document Type: Article
Times cited : (5)

References (18)
  • 2
    • 33746162016 scopus 로고    scopus 로고
    • Pharmacokinetics and bioequivalence evaluation of risperidone in healthy male subjects with different CYP2D6 genotypes
    • Cho HY, Lee YB. Pharmacokinetics and bioequivalence evaluation of risperidone in healthy male subjects with different CYP2D6 genotypes. Arch Pharm Res. 2006; 29: 525-533.
    • (2006) Arch Pharm Res , vol.29 , pp. 525-533
    • Cho, H.Y.1    Lee, Y.B.2
  • 3
    • 34250181141 scopus 로고    scopus 로고
    • Note for guidance on the investigation of bioavailability and bioequivalence
    • CPMP Committee for Proprietary Medicinal Products, CPMP/EWP/QWP/1401/98
    • CPMP Committee for Proprietary Medicinal Products. Note for guidance on the investigation of bioavailability and bioequivalence. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit. 2001; (CPMP/EWP/QWP/1401/98).
    • (2001) The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit
  • 4
    • 0025958371 scopus 로고
    • Sample size determination for bioequivalence assessment by means of confidence intervals
    • Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991; 29: 1-8.
    • (1991) Int J Clin Pharmacol Ther Toxicol , vol.29 , pp. 1-8
    • Diletti, E.1    Hauschke, D.2    Steinijans, V.W.3
  • 5
    • 0029969184 scopus 로고    scopus 로고
    • Pharmacokinetics and drug interactions: Update for new antipsychotics
    • Ereshefsky L. Pharmacokinetics and drug interactions: update for new antipsychotics. J Clin Psychiatry 1996; 57 (Suppl. 11): 12-25.
    • (1996) J Clin Psychiatry , vol.57 , Issue.SUPPL. 11 , pp. 12-25
    • Ereshefsky, L.1
  • 6
    • 0033063442 scopus 로고    scopus 로고
    • Metabolism of risperidone to 9-hydroxyrisperidone by human cytochromes P450 2D6 and 3A4
    • Fang J, Bourin M, Baker GB. Metabolism of risperidone to 9-hydroxyrisperidone by human cytochromes P450 2D6 and 3A4. Naunyn Schmiedebergs Arch Pharmacol. 1999; 359: 147-151.
    • (1999) Naunyn Schmiedebergs Arch Pharmacol , vol.359 , pp. 147-151
    • Fang, J.1    Bourin, M.2    Baker, G.B.3
  • 7
    • 0028096538 scopus 로고
    • Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia
    • Grant S, Fitton A. Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs. 1994; 48: 253-273.
    • (1994) Drugs , vol.48 , pp. 253-273
    • Grant, S.1    Fitton, A.2
  • 9
    • 0025332058 scopus 로고
    • A distribution-free procedure for the statistical analysis of bioequivalence studies
    • Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990; 28: 72-78.
    • (1990) Int J Clin Pharmacol Ther Toxicol , vol.28 , pp. 72-78
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3
  • 10
    • 85036839693 scopus 로고    scopus 로고
    • Health Canada. Guidance for Industry. Drugs Directorate Guidelines. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral dosage formulations used for systemic effects. Minister of Public Works and Government Services Canada, 1992; (H42-2/ 56-1992E).
    • Health Canada. Guidance for Industry. Drugs Directorate Guidelines. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral dosage formulations used for systemic effects. Minister of Public Works and Government Services Canada, 1992; (H42-2/ 56-1992E).
  • 13
    • 85036812273 scopus 로고    scopus 로고
    • Good Clinical Practise: Consolidated Guidance;
    • ICH E6. Good Clinical Practise: Consolidated Guidance; 1996.
    • (1996) ICH E6
  • 14
    • 19044381358 scopus 로고    scopus 로고
    • Risperidone: A review
    • Möller HJ. Risperidone: a review. Expert Opin Pharmacother. 2005; 6: 803-818.
    • (2005) Expert Opin Pharmacother , vol.6 , pp. 803-818
    • HJ, M.1
  • 15
    • 85036819113 scopus 로고    scopus 로고
    • Risperdal® SmPC. Electronic Medicines Compendium. www.medicines.org.uk; 2004.
    • (2004)
    • Risperdal®, S.P.C.1
  • 16
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987; 15: 657-680.
    • (1987) J Pharmacokinet Biopharm , vol.15 , pp. 657-680
    • DJ, S.1
  • 18
    • 0028417402 scopus 로고
    • Updates of bioequivalence programs (including statistical power approximated by Student's t)
    • Wijnand HP. Updates of bioequivalence programs (including statistical power approximated by Student's t). Comput Methods Programs Biomed. 1994; 42: 275-281.
    • (1994) Comput Methods Programs Biomed , vol.42 , pp. 275-281
    • HP, W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.