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Volumn 34, Issue 4, 2012, Pages 966-978

Steady-State Plasma Concentration Profile of Transdermal Rotigotine: An Integrated Analysis of Three, Open-Label, Randomized, Phase I Multiple Dose Studies**Results of study SP630 were partially presented at the 58th Annual Meeting of the American Academy of Neurology, San Diego, California, April 1-8, 2006, and at the 9th Cong

Author keywords

Application site; Bioavailability; Continuous 24 hour drug delivery; Dose proportionality; Rotigotine transdermal patch; Steady state pharmacokinetic profile

Indexed keywords

ROTIGOTINE;

EID: 84859611783     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.02.008     Document Type: Article
Times cited : (96)

References (25)
  • 1
    • 0035353725 scopus 로고    scopus 로고
    • Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature
    • Ahlskog J.E., Muenter M.D. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord 2001, 16:448-458.
    • (2001) Mov Disord , vol.16 , pp. 448-458
    • Ahlskog, J.E.1    Muenter, M.D.2
  • 2
    • 0033695789 scopus 로고    scopus 로고
    • Continuous dopamine-receptor stimulation in early Parkinson's disease
    • Olanow C.W., Schapira A.H., Rascol O. Continuous dopamine-receptor stimulation in early Parkinson's disease. Trends Neurosc 2000, 23(Suppl):S117-S126.
    • (2000) Trends Neurosc , vol.23 , Issue.SUPPL.
    • Olanow, C.W.1    Schapira, A.H.2    Rascol, O.3
  • 3
    • 67649377884 scopus 로고    scopus 로고
    • Accessed February 28, 2012
    • Neupro® transdermal patch. Package Label Accessed February 28, 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000626/WC500026397.pdf.
    • Neupro® transdermal patch. Package Label
  • 4
    • 70349302129 scopus 로고    scopus 로고
    • Absorption, disposition, metabolic fate, and elimination of the dopamine agonist rotigotine in man: administration by intravenous infusion or transdermal delivery
    • Cawello W., Braun M., Boekens H. Absorption, disposition, metabolic fate, and elimination of the dopamine agonist rotigotine in man: administration by intravenous infusion or transdermal delivery. Drug Metabol Dispos 2009, 37:2055-2060.
    • (2009) Drug Metabol Dispos , vol.37 , pp. 2055-2060
    • Cawello, W.1    Braun, M.2    Boekens, H.3
  • 5
    • 33846438955 scopus 로고    scopus 로고
    • Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease
    • Watts R.L., Jankovic J., Waters C., et al. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007, 68:272-276.
    • (2007) Neurology , vol.68 , pp. 272-276
    • Watts, R.L.1    Jankovic, J.2    Waters, C.3
  • 6
    • 34248372064 scopus 로고    scopus 로고
    • Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial
    • Poewe W.H., Rascol O., Quinn N., et al. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol 2007, 6:513-520.
    • (2007) Lancet Neurol , vol.6 , pp. 513-520
    • Poewe, W.H.1    Rascol, O.2    Quinn, N.3
  • 7
    • 40849113591 scopus 로고    scopus 로고
    • Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe
    • Oertel W.H., Beneš H., García-Borreguero D., et al. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med 2008, 9:228-239.
    • (2008) Sleep Med , vol.9 , pp. 228-239
    • Oertel, W.H.1    Beneš, H.2    García-Borreguero, D.3
  • 8
    • 49849083845 scopus 로고    scopus 로고
    • Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial
    • Trenkwalder C., Beneš H., Poewe W., et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2008, 7:595-604.
    • (2008) Lancet Neurol , vol.7 , pp. 595-604
    • Trenkwalder, C.1    Beneš, H.2    Poewe, W.3
  • 9
    • 61349192144 scopus 로고    scopus 로고
    • Influence of domperidone on pharmacokinetics, safety and tolerability of the dopamine agonist rotigotine
    • Braun M., Cawello W., Boekens H., Horstmann R. Influence of domperidone on pharmacokinetics, safety and tolerability of the dopamine agonist rotigotine. Br Jl Clin Pharmacol 2009, 67:209-215.
    • (2009) Br Jl Clin Pharmacol , vol.67 , pp. 209-215
    • Braun, M.1    Cawello, W.2    Boekens, H.3    Horstmann, R.4
  • 10
    • 34548836698 scopus 로고    scopus 로고
    • Characteristics of rotigotine elimination after patch removal
    • (abstract no.P1164)
    • Cawello W., Elshoff J.P., Boekens H., et al. Characteristics of rotigotine elimination after patch removal. Euro J Neurol 2006, 13(Suppl 2):85. (abstract no.P1164).
    • (2006) Euro J Neurol , vol.13 , Issue.SUPPL. 2 , pp. 85
    • Cawello, W.1    Elshoff, J.P.2    Boekens, H.3
  • 12
    • 34547102981 scopus 로고    scopus 로고
    • Continuous delivery of rotigotine decreases extracellular dopamine suggesting continuous receptor stimulation
    • Kehr J., Hu X.J., Goiny M., Scheller D. Continuous delivery of rotigotine decreases extracellular dopamine suggesting continuous receptor stimulation. J Neural Transm 2007, 114:1027-1031.
    • (2007) J Neural Transm , vol.114 , pp. 1027-1031
    • Kehr, J.1    Hu, X.J.2    Goiny, M.3    Scheller, D.4
  • 13
    • 69949101386 scopus 로고    scopus 로고
    • Continuous administration of rotigotine to MPTP-treated common marmosets enhances anti-parkinsonian activity and reduces dyskinesia induction
    • Stockwell K.A., Scheller D., Rose S., et al. Continuous administration of rotigotine to MPTP-treated common marmosets enhances anti-parkinsonian activity and reduces dyskinesia induction. Expl Neurol 2009, 219:533-542.
    • (2009) Expl Neurol , vol.219 , pp. 533-542
    • Stockwell, K.A.1    Scheller, D.2    Rose, S.3
  • 14
    • 52449089646 scopus 로고    scopus 로고
    • Continuous versus pulsatile administration of rotigotine in 6-OHDA-lesioned rats: contralateral rotations and abnormal involuntary movements
    • Schmidt W.J., Lebsanft H., Heindl M., et al. Continuous versus pulsatile administration of rotigotine in 6-OHDA-lesioned rats: contralateral rotations and abnormal involuntary movements. J Neural Transm 2008, 115:1385-1392.
    • (2008) J Neural Transm , vol.115 , pp. 1385-1392
    • Schmidt, W.J.1    Lebsanft, H.2    Heindl, M.3
  • 15
    • 4644321549 scopus 로고    scopus 로고
    • Movement Disorder Society task force report on the Hoehn and Yahr staging scale: status and recommendations
    • Goetz C.G., Poewe W., Rascol O., et al. Movement Disorder Society task force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord 2004, 19:1020-1028.
    • (2004) Mov Disord , vol.19 , pp. 1020-1028
    • Goetz, C.G.1    Poewe, W.2    Rascol, O.3
  • 18
    • 33645228681 scopus 로고    scopus 로고
    • Food and Drug Administration, Guidance for Industry, US Department of Health and Human Services, Center for Drug Evaluation and Research, Washington, DC
    • Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products 1999, Food and Drug Administration, Guidance for Industry, US Department of Health and Human Services, Center for Drug Evaluation and Research, Washington, DC.
    • (1999) Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products
  • 19
    • 0003478656 scopus 로고    scopus 로고
    • European Medicines Agency, The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP), London, UK
    • Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98, rev. 1) 2001, European Medicines Agency, The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP), London, UK.
    • (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98, rev. 1)
  • 20
    • 0003922012 scopus 로고    scopus 로고
    • Food and Drug Administration, Guidance for Industry, Accessed February 28, 2012
    • Statistical approaches to establishing bioequivalence Food and Drug Administration, Guidance for Industry, Accessed February 28, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070244.pdf.
    • Statistical approaches to establishing bioequivalence
  • 21
    • 54249107164 scopus 로고    scopus 로고
    • Thorough QT/QTc study in patients with advanced Parkinson's disease: cardiac safety of rotigotine
    • Malik M., Andreas J.-O., Hnatkova K., et al. Thorough QT/QTc study in patients with advanced Parkinson's disease: cardiac safety of rotigotine. Clin Pharmacol Therap 2008, 84:595-603.
    • (2008) Clin Pharmacol Therap , vol.84 , pp. 595-603
    • Malik, M.1    Andreas, J.-O.2    Hnatkova, K.3
  • 22
    • 0003065234 scopus 로고
    • Properties that influence percutaneous absorption
    • Marcel Dekker Inc., New York, J. Swarbrick (Ed.)
    • Barry B. Properties that influence percutaneous absorption. Dermatological Formulations; Percutaneous Absorption 1983, 127-233. Marcel Dekker Inc., New York. J. Swarbrick (Ed.).
    • (1983) Dermatological Formulations; Percutaneous Absorption , pp. 127-233
    • Barry, B.1
  • 23
    • 38549159427 scopus 로고    scopus 로고
    • Rotigotine transdermal patch in early Parkinson's disease: a randomized, double-blind, controlled study versus placebo and ropinirole
    • Giladi N., Boroojerdi B., Korczyn A.D., et al. Rotigotine transdermal patch in early Parkinson's disease: a randomized, double-blind, controlled study versus placebo and ropinirole. Mov Disord 2007, 22:2398-2404.
    • (2007) Mov Disord , vol.22 , pp. 2398-2404
    • Giladi, N.1    Boroojerdi, B.2    Korczyn, A.D.3
  • 24
    • 0346754905 scopus 로고    scopus 로고
    • A controlled trial of rotigotine monotherapy in early Parkinson's disease
    • The Parkinson Study Group
    • A controlled trial of rotigotine monotherapy in early Parkinson's disease. Arch Neurol 2003, 60:1721-1728. The Parkinson Study Group.
    • (2003) Arch Neurol , vol.60 , pp. 1721-1728
  • 25
    • 77956180778 scopus 로고    scopus 로고
    • High compliance with rotigotine transdermal patch in the treatment of idiopathic Parkinson's disease
    • Schnitzler A., Leffers K.-W., Häck H.-J. High compliance with rotigotine transdermal patch in the treatment of idiopathic Parkinson's disease. Parkinson Related Disord 2010, 16:513-516.
    • (2010) Parkinson Related Disord , vol.16 , pp. 513-516
    • Schnitzler, A.1    Leffers, K.-W.2    Häck, H.-J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.