메뉴 건너뛰기




Volumn 39, Issue 4, 2007, Pages 1233-1236

Bioavailability of a New Generic Formulation of Mycophenolate Mofetil MMF 500 Versus CellCept in Healthy Adult Volunteers

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; HEPARIN; LIVER ENZYME; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PARACETAMOL;

EID: 34249038135     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.transproceed.2007.03.055     Document Type: Article
Times cited : (12)

References (23)
  • 1
    • 0029006409 scopus 로고    scopus 로고
    • Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for the prevention of acute rejection
    • European Mycophenolate Mofetil Cooperative Study Group
    • European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for the prevention of acute rejection. Lancet 345 (1998) 1321
    • (1998) Lancet , vol.345 , pp. 1321
  • 2
    • 0006986048 scopus 로고    scopus 로고
    • A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation
    • The International Mycophenolate Mofetil Renal Transplantation Study Group
    • The International Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation 61 (1996) 1029
    • (1996) Transplantation , vol.61 , pp. 1029
  • 3
    • 0029922910 scopus 로고    scopus 로고
    • Mycophenolate mofetil for the treatment of refractory, acute, cellular renal transplant rejection
    • The Mycophenolate Mofetil Renal Refrectory Rejection Study Group
    • The Mycophenolate Mofetil Renal Refrectory Rejection Study Group. Mycophenolate mofetil for the treatment of refractory, acute, cellular renal transplant rejection. Transplantation 61 (1996) 722
    • (1996) Transplantation , vol.61 , pp. 722
  • 4
    • 0031024728 scopus 로고
    • Mycophenolate mofetil in renal allograft receipents. A pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection
    • Halloran P., Mathew T., Tomlanovich S., et al. Mycophenolate mofetil in renal allograft receipents. A pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection. Transplnatation 63 (1993) 39
    • (1993) Transplnatation , vol.63 , pp. 39
    • Halloran, P.1    Mathew, T.2    Tomlanovich, S.3
  • 5
    • 0005567232 scopus 로고    scopus 로고
    • Steroid withdrawal in mycophenolate mofetil-treated renal allograft recipients
    • Grinyo J.M., Gil-Vernet S., Seron D., et al. Steroid withdrawal in mycophenolate mofetil-treated renal allograft recipients. Transplanation 63 (1997) 168
    • (1997) Transplanation , vol.63 , pp. 168
    • Grinyo, J.M.1    Gil-Vernet, S.2    Seron, D.3
  • 6
    • 0033253676 scopus 로고    scopus 로고
    • A one-center experience with a shortcourse of mycophenolic acid
    • Stephan A., Barbari A., Kamel G., et al. A one-center experience with a shortcourse of mycophenolic acid. Transplant Proc 31 (1999) 3289
    • (1999) Transplant Proc , vol.31 , pp. 3289
    • Stephan, A.1    Barbari, A.2    Kamel, G.3
  • 7
    • 0003478656 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP) Available: http://www.emea. Accessed October 22, 2003
    • Committee for Proprietary Medicinal Products (CPMP). Notes for guidance on the investigation of bioavailability and bioequivalence (2001). http://www.emea Available: http://www.emea. Accessed October 22, 2003
    • (2001) Notes for guidance on the investigation of bioavailability and bioequivalence
  • 8
    • 34248993190 scopus 로고    scopus 로고
    • Food and Drug Administration Center for Drug Evaluation and Research: Approved drug products with therapeutic equivalence evaluations prescribing information. Available: http://www.fda.gov. Accessed October 22, 2003
  • 9
    • 0000928683 scopus 로고
    • Bioavailability and bioequivalence requirements
    • Food and Drug Administration (FDA)
    • Food and Drug Administration (FDA). Bioavailability and bioequivalence requirements. Fed Regist 57 (1992) 17997
    • (1992) Fed Regist , vol.57 , pp. 17997
  • 10
    • 0842303344 scopus 로고    scopus 로고
    • The role of generics in transplantation. TM-MMF vs Cellcept in healthy volunteers
    • Masri M.A., Andrysek T., Rizk S., et al. The role of generics in transplantation. TM-MMF vs Cellcept in healthy volunteers. Transplant Proc 36 (2004) 84
    • (2004) Transplant Proc , vol.36 , pp. 84
    • Masri, M.A.1    Andrysek, T.2    Rizk, S.3
  • 11
    • 0033665006 scopus 로고    scopus 로고
    • Cyclosporine formulations: is there really a difference?
    • Masri M.A., Stephan A., Barbari A., et al. Cyclosporine formulations: is there really a difference?. Transplant Proc 32 (2000) 1468
    • (2000) Transplant Proc , vol.32 , pp. 1468
    • Masri, M.A.1    Stephan, A.2    Barbari, A.3
  • 12
    • 0033251807 scopus 로고    scopus 로고
    • Safe and cost effective conversion from Neoral to Consupren soft gelatin capsules in stable renal transplant patients: a 1-year study
    • Masri M.A., Barbari A., Stephan A., et al. Safe and cost effective conversion from Neoral to Consupren soft gelatin capsules in stable renal transplant patients: a 1-year study. Transplant Proc 31 (1999) 3302
    • (1999) Transplant Proc , vol.31 , pp. 3302
    • Masri, M.A.1    Barbari, A.2    Stephan, A.3
  • 13
    • 0032210490 scopus 로고    scopus 로고
    • A one-year comparative study of Neoral vs Consupren in de novo renal transplant patients
    • Stephan A., Masri M.A., Barbari A., et al. A one-year comparative study of Neoral vs Consupren in de novo renal transplant patients. Transplant Proc 30 (1998) 3533
    • (1998) Transplant Proc , vol.30 , pp. 3533
    • Stephan, A.1    Masri, M.A.2    Barbari, A.3
  • 14
    • 0030828709 scopus 로고    scopus 로고
    • Experience with new cyclosporine formulations: Consupren and Neoral in renal transplant patients
    • Barbari A., Stephan A., Kamel G., et al. Experience with new cyclosporine formulations: Consupren and Neoral in renal transplant patients. Transplant Proc 29 (1997) 2941
    • (1997) Transplant Proc , vol.29 , pp. 2941
    • Barbari, A.1    Stephan, A.2    Kamel, G.3
  • 15
    • 0029882387 scopus 로고    scopus 로고
    • Evaluation of the new cyclosporine formulation, Consupren, in renal transplant patients
    • Stephan A., Barbari A., Masri M.A., et al. Evaluation of the new cyclosporine formulation, Consupren, in renal transplant patients. Transplant Proc 28 (1996) 1348
    • (1996) Transplant Proc , vol.28 , pp. 1348
    • Stephan, A.1    Barbari, A.2    Masri, M.A.3
  • 16
    • 0029989138 scopus 로고    scopus 로고
    • Cyclosporine pharmacokinetics in stable renal transplant patients: effect of formulation Sandimmun versus Consupren versus Neoral
    • Masri M.A., Barbari A., Stephan A., et al. Cyclosporine pharmacokinetics in stable renal transplant patients: effect of formulation Sandimmun versus Consupren versus Neoral. Transplant Proc 28 (1996) 1318
    • (1996) Transplant Proc , vol.28 , pp. 1318
    • Masri, M.A.1    Barbari, A.2    Stephan, A.3
  • 17
    • 0036260004 scopus 로고    scopus 로고
    • Comparison of bioavailability and metabolism with two commercial formulations of cyclosporine A in rats
    • Koehler J., Kuehnel T., Kees F., et al. Comparison of bioavailability and metabolism with two commercial formulations of cyclosporine A in rats. Drug Metab Dispos 30 (2002) 658
    • (2002) Drug Metab Dispos , vol.30 , pp. 658
    • Koehler, J.1    Kuehnel, T.2    Kees, F.3
  • 18
    • 0032912960 scopus 로고    scopus 로고
    • Generic immunosuppressant use in solid organ transplantation
    • Alloway R.R. Generic immunosuppressant use in solid organ transplantation. Transplant Proc 31 (1999) 2S
    • (1999) Transplant Proc , vol.31
    • Alloway, R.R.1
  • 19
    • 0031754486 scopus 로고    scopus 로고
    • Development of Sang-35: a cyclosporine formulation bioequivalent to Neoral
    • First M.R., Alloway R., and Schroder T.J. Development of Sang-35: a cyclosporine formulation bioequivalent to Neoral. Clin Transplant 12 (1998) 318
    • (1998) Clin Transplant , vol.12 , pp. 318
    • First, M.R.1    Alloway, R.2    Schroder, T.J.3
  • 20
    • 0037108716 scopus 로고    scopus 로고
    • Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation
    • Roza A., Tomlanovich S., Merion R., et al. Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation. Transplantation 74 (2000) 1013
    • (2000) Transplantation , vol.74 , pp. 1013
    • Roza, A.1    Tomlanovich, S.2    Merion, R.3
  • 22
    • 0038045086 scopus 로고    scopus 로고
    • A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A
    • Pollard S., Nashan B., Johnston A., et al. A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A. Clin Ther 25 (2003) 1654
    • (2003) Clin Ther , vol.25 , pp. 1654
    • Pollard, S.1    Nashan, B.2    Johnston, A.3
  • 23
    • 0842321544 scopus 로고    scopus 로고
    • The generics in transplantation and the rules on their use
    • Masri M.A. The generics in transplantation and the rules on their use. Exp Clin Transplant 1 (2003) 65
    • (2003) Exp Clin Transplant , vol.1 , pp. 65
    • Masri, M.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.