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Volumn 47, Issue 12, 2009, Pages 761-769

Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers

Author keywords

Bioequivalence; Equasym Retard; Extended release; Medikinet retard; Methylphenidate

Indexed keywords

METHYLPHENIDATE;

EID: 71849112238     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP47761     Document Type: Article
Times cited : (11)

References (25)
  • 5
    • 85036781814 scopus 로고    scopus 로고
    • Eurand Inc, accessed April 21, 2009
    • Eurand Inc. Diffucaps (online). http://www.eurand.com/ Technologies/Controlling-Drug-Release/Diffucaps/Vandalia: Eurand; accessed April 21, 2009.
    • Diffucaps (online)
  • 6
    • 33644785715 scopus 로고    scopus 로고
    • Bioequivalence of a methylphenidate hydrochloride extended-release preparation: Comparison of an intact capsule and an opened capsule sprinkled on apple-sauce
    • Fischer R, Schütz H, Grossmann M, Leis HJ, Ammer R. Bioequivalence of a methylphenidate hydrochloride extended-release preparation: comparison of an intact capsule and an opened capsule sprinkled on apple-sauce. Int J Clin Pharmacol Ther. 2006; 44: 135-141.
    • (2006) Int J Clin Pharmacol Ther , vol.44 , pp. 135-141
    • Fischer, R.1    Schütz, H.2    Grossmann, M.3    Leis, H.J.4    Ammer, R.5
  • 7
    • 52149084789 scopus 로고    scopus 로고
    • A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers
    • Haessler F, Tracik F, Dietrich H, Stammer H, Klatt J. A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers. Int J Clin Pharmacol Ther. 2008; 46: 466-476.
    • (2008) Int J Clin Pharmacol Ther , vol.46 , pp. 466-476
    • Haessler, F.1    Tracik, F.2    Dietrich, H.3    Stammer, H.4    Klatt, J.5
  • 8
    • 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 Pharm Ther Toxicol. 1990; 28: 72-78.
    • (1990) Int J Clin Pharm Ther Toxicol , vol.28 , pp. 72-78
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3
  • 10
    • 0033807834 scopus 로고    scopus 로고
    • Negative ion chemical ionization for the determination of methylphenidate in human plasma by stable isotope dilution gas chromatography/mass spectrometry
    • Leis HJ, Fauler G, Raspotnig G, Windischhofer W. Negative ion chemical ionization for the determination of methylphenidate in human plasma by stable isotope dilution gas chromatography/mass spectrometry. J Mass Spectrom. 2000; 35: 1100-1104.
    • (2000) J Mass Spectrom , vol.35 , pp. 1100-1104
    • Leis, H.J.1    Fauler, G.2    Raspotnig, G.3    Windischhofer, W.4
  • 12
    • 85036792464 scopus 로고    scopus 로고
    • MEDICE Arzneimittel Pütter GmbH & Co. KG. Zusammenfassung derMerkmale des Arzneimittels (Summary of Product Characteristics): Medikinet retard 10 mg/20 mg/30 mg/40 mg. Iserlohn: Medice; 2006.
    • MEDICE Arzneimittel Pütter GmbH & Co. KG. Zusammenfassung derMerkmale des Arzneimittels (Summary of Product Characteristics): Medikinet retard 10 mg/20 mg/30 mg/40 mg. Iserlohn: Medice; 2006.
  • 14
    • 0033668829 scopus 로고    scopus 로고
    • Dose-proportional and stereospecific pharmacokinetics of methylphenidate delivered using an osmotic, controlled-release oral delivery system
    • Modi NB, Wang B, Noveck RJ, Gupta SK. Dose-proportional and stereospecific pharmacokinetics of methylphenidate delivered using an osmotic, controlled-release oral delivery system. J Clin Pharmacol. 2000; 40: 1141-1149.
    • (2000) J Clin Pharmacol , vol.40 , pp. 1141-1149
    • Modi, N.B.1    Wang, B.2    Noveck, R.J.3    Gupta, S.K.4
  • 15
    • 1842533979 scopus 로고    scopus 로고
    • National Institute of Mental Health Multimodal Treatment Study of ADHD Follow-up: 24-month outcomes of treatment strategies for attention deficit/hyperactivity disorder
    • MTA Cooperative Group
    • MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD Follow-up: 24-month outcomes of treatment strategies for attention deficit/hyperactivity disorder. Pediatrics. 2004; 113: 754-761.
    • (2004) Pediatrics , vol.113 , pp. 754-761
  • 17
    • 85036799068 scopus 로고    scopus 로고
    • Patrick KS, Mueller RA, Gualtieri CT, Breese GR. Pharmacokinetics and actions of methylphenidate. In: Meltzer HY. Psychopharmacology: the third generation of progress. New York: Raven Press; 1987, 1387-1395.
    • Patrick KS, Mueller RA, Gualtieri CT, Breese GR. Pharmacokinetics and actions of methylphenidate. In: Meltzer HY. Psychopharmacology: the third generation of progress. New York: Raven Press; 1987, 1387-1395.
  • 18
    • 70149113077 scopus 로고    scopus 로고
    • R Foundation for Statistical Computing, Vienna, Austria;, ISBN 3-900051-07-0
    • R Development Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria; 2009, ISBN 3-900051-07-0, http://www.R-project.org.
    • (2009) R: A language and environment for statistical computing
  • 19
    • 2542490282 scopus 로고    scopus 로고
    • Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule
    • Rochdi M, González MA, Hirshey Dirksen SJ. Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule. Int J Clin Pharmacol Ther. 2004; 42: 285-292.
    • (2004) Int J Clin Pharmacol Ther , vol.42 , pp. 285-292
    • Rochdi, M.1    González, M.A.2    Hirshey Dirksen, S.J.3
  • 20
    • 0037317368 scopus 로고    scopus 로고
    • Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder
    • Swanson J, Lam A, Shoulson I, Lerner M, Modi N, Lindemulder E, Wigal S. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 2003; 60: 204-211.
    • (2003) Arch Gen Psychiatry , vol.60 , pp. 204-211
    • Swanson, J.1    Lam, A.2    Shoulson, I.3    Lerner, M.4    Modi, N.5    Lindemulder, E.6    Wigal, S.7
  • 23
    • 37249021434 scopus 로고    scopus 로고
    • Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethylphenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man
    • Tuerck D, Wang Y, Maboudian M, Wang Y, Sedek G, Pommier F, Appel-Dingemanse S. Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethylphenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man. Int J Clin Pharmacol Ther. 2007; 45: 662-668.
    • (2007) Int J Clin Pharmacol Ther , vol.45 , pp. 662-668
    • Tuerck, D.1    Wang, Y.2    Maboudian, M.3    Wang, Y.4    Sedek, G.5    Pommier, F.6    Appel-Dingemanse, S.7
  • 25
    • 12144286002 scopus 로고    scopus 로고
    • Singh Rekhi G, Lau H, Sedek G, Hossain M. In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal release formulation in healthy volunteers
    • Wang Y, Lee L, Somma R, ThompsonG, Bakhtiar R, Lee J, Singh Rekhi G, Lau H, Sedek G, Hossain M. In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal release formulation in healthy volunteers. Biopharm Drug Dispos. 2004; 25: 91-98.
    • (2004) Biopharm Drug Dispos , vol.25 , pp. 91-98
    • Wang, Y.1    Lee, L.2    Somma, R.3    Thompson, G.4    Bakhtiar, R.5    Lee, J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.