메뉴 건너뛰기




Volumn 3, Issue 4, 2003, Pages 219-223

Bioequivalence of azathioprine products

Author keywords

6 Mercaptopurine; Azathioprine; Bioavailability; Bioequivance; Pharmacogenetics; Thiopurine methytransferase (TPMT)

Indexed keywords

AZATHIOPRINE; AZATHIOPRINE DERIVATIVE; CARBAMAZEPINE; CYCLOSPORIN; DIGOXIN; DRUG METABOLITE; DRUG METABOLIZING ENZYME; LEVOTHYROXINE; MERCAPTOPURINE; PHENYTOIN; STEROID; TACROLIMUS; THEOPHYLLINE; THIOPURINE METHYLTRANSFERASE; TIOGUANINE; WARFARIN;

EID: 0347589254     PISSN: 1533001X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (3)

References (40)
  • 1
    • 0033044557 scopus 로고    scopus 로고
    • Drug substitution in transplantation: A National Kidney Foundation White Paper
    • Sabatini S, Ferguson RM, Helderman JH, et al. Drug substitution in transplantation: a National Kidney Foundation White Paper. Am J Kidney Dis. 1999;33:389-397.
    • (1999) Am. J. Kidney Dis. , vol.33 , pp. 389-397
    • Sabatini, S.1    Ferguson, R.M.2    Helderman, J.H.3
  • 2
    • 0344267647 scopus 로고    scopus 로고
    • Transplant pharmacists' opinions on generic product selection of critical-dose drugs
    • Vasquez EM, Min DI. Transplant pharmacists' opinions on generic product selection of critical-dose drugs. Am J Health-Syst Pharm. 1999;56:615-621.
    • (1999) Am. J. Health-Syst. Pharm. , vol.56 , pp. 615-621
    • Vasquez, E.M.1    Min, D.I.2
  • 3
    • 0035571150 scopus 로고    scopus 로고
    • Clinical pharmacology and therapeutic use of the new antiepileptic drugs
    • Perucca E. Clinical pharmacology and therapeutic use of the new antiepileptic drugs. Fund Clin Pharmacol. 2001;15:405-417.
    • (2001) Fund. Clin. Pharmacol. , vol.15 , pp. 405-417
    • Perucca, E.1
  • 4
    • 0036208713 scopus 로고    scopus 로고
    • Therapeutic drug monitoring of immunosuppressant drugs in clinical practice
    • Kahan BD, Keown P, Levy GA, Johnston A. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther. 2002;24:330-350.
    • (2002) Clin. Ther. , vol.24 , pp. 330-350
    • Kahan, B.D.1    Keown, P.2    Levy, G.A.3    Johnston, A.4
  • 5
    • 0035166981 scopus 로고    scopus 로고
    • Issues in the use of generic antiarrhythmic drugs
    • Reiffel JA. Issues in the use of generic antiarrhythmic drugs. Curr Opinion Cardiol. 2001; 16:23-29.
    • (2001) Curr. Opinion Cardiol. , vol.16 , pp. 23-29
    • Reiffel, J.A.1
  • 6
    • 0033668377 scopus 로고    scopus 로고
    • Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin
    • Yacobi A, Masson E, Moros D, et al. Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin. J Clin Pharmacol. 2000;40:826-835.
    • (2000) J. Clin. Pharmacol. , vol.40 , pp. 826-835
    • Yacobi, A.1    Masson, E.2    Moros, D.3
  • 7
    • 0032938263 scopus 로고    scopus 로고
    • Management of narrow therapeutic index drugs
    • Burns M. Management of narrow therapeutic index drugs. J Thromb Thrombolysis. 1999; 7:137-143.
    • (1999) J. Thromb. Thrombolysis , vol.7 , pp. 137-143
    • Burns, M.1
  • 8
    • 0033135372 scopus 로고    scopus 로고
    • Relevance of pharmacokinetics in narrow therapeutic index drugs
    • Benet LZ. Relevance of pharmacokinetics in narrow therapeutic index drugs. Transplantation Proc. 1999;31:1642-1644.
    • (1999) Transplantation Proc. , vol.31 , pp. 1642-1644
    • Benet, L.Z.1
  • 9
    • 0031836875 scopus 로고    scopus 로고
    • What are narrow therapeutic index drugs?
    • Levy G. What are narrow therapeutic index drugs? Clin Pharmacol Ther. 1998;63:501-505.
    • (1998) Clin. Pharmacol. Ther. , vol.63 , pp. 501-505
    • Levy, G.1
  • 10
    • 0005500264 scopus 로고    scopus 로고
    • Therapeutic equivalence of generic drugs: Letter to health professionals
    • Center for Drug Evaluation. Food and Drug Administration web site. February 4, 1998. Available at: Accessed June 4
    • Nightingale SL. Therapeutic equivalence of generic drugs: letter to health professionals. Center for Drug Evaluation. Food and Drug Administration web site. February 4, 1998. Available at: http://www.fda.gov/cder/news/nightgenlett.htm. Accessed June 4, 2003.
    • (2003)
    • Nightingale, S.L.1
  • 11
    • 0344887833 scopus 로고    scopus 로고
    • Therapeutic equivalence of generic drugs: Response to National Association of Boards of Pharmacy
    • [letter]. Center for Drug Evaluation and Research. Food and Drug Administration web site. April 16, 1997. Available at: Accessed June 4
    • Williams RL. Therapeutic equivalence of generic drugs: response to National Association of Boards of Pharmacy [letter]. Center for Drug Evaluation and Research. Food and Drug Administration web site. April 16, 1997. Available at: http://www.fda.gov/cder/news/ntiletter.htm. Accessed June 4, 2003.
    • (2003)
    • Williams, R.L.1
  • 12
    • 0346468701 scopus 로고    scopus 로고
    • FDA Advisory Committee for Pharmaceutical Sciences' Briefing Document: Levothyroxine Bioequivalence. Abbott Park, Ill: Abbott Laboratories; March
    • FDA Advisory Committee for Pharmaceutical Sciences' Briefing Document: Levothyroxine Bioequivalence. Abbott Park, Ill: Abbott Laboratories; March 2003.
    • (2003)
  • 13
    • 0032914003 scopus 로고    scopus 로고
    • The impact of generic drugs on the cost of transplantation medical care
    • Olyaei AJ, deMattos AM, Bennett WM. The impact of generic drugs on the cost of transplantation medical care. Transplantation Proc. 1999;31(suppl 3A):31S-34S.
    • (1999) Transplantation Proc. , vol.31 , Issue.SUPPL. 3A
    • Olyaei, A.J.1    deMattos, A.M.2    Bennett, W.M.3
  • 14
    • 0032915969 scopus 로고    scopus 로고
    • Cyclosporine: The case for expanding bioequivalence criteria to include measures of individual bioequivalence in relevant population subsets
    • Barr WH. Cyclosporine: the case for expanding bioequivalence criteria to include measures of individual bioequivalence in relevant population subsets. Transplantation Proc. 1999; 31(suppl 3A):25S-30S.
    • (1999) Transplantation Proc. , vol.31 , Issue.SUPPL. 3A
    • Barr, W.H.1
  • 15
    • 0003547433 scopus 로고    scopus 로고
    • Approved drug products with therapeutic equivalence evaluations
    • Food and Drug Administration Center for Drug Evaluation and Research. 23rd Edition. May 2003. Available at: Accessed July 10
    • Food and Drug Administration Center for Drug Evaluation and Research. Approved drug products with therapeutic equivalence evaluations. 23rd Edition. May 2003. Available at: http://www.fda.gov/cder/ob/default.htm. Accessed July 10, 2003.
    • (2003)
  • 16
    • 0035659563 scopus 로고    scopus 로고
    • Bioavailability and bioequivalence: An FDA regulatory overview
    • Chen ML, Shah V, Patnaik R, et al. Bioavailability and bioequivalence: an FDA regulatory overview. Pharmaceutical Res. 2001; 18:1645-1650.
    • (2001) Pharmaceutical Res. , vol.18 , pp. 1645-1650
    • Chen, M.L.1    Shah, V.2    Patnaik, R.3
  • 17
    • 0032938160 scopus 로고    scopus 로고
    • A review of the safety of generic drugs
    • Dighe SV. A review of the safety of generic drugs. Transplantation Proceedings. 1999; 31(suppl 3A):23S-24S.
    • (1999) Transplantation Proceedings , vol.31 , Issue.SUPPL. 3A
    • Dighe, S.V.1
  • 18
    • 0345837817 scopus 로고    scopus 로고
    • Guidance for industry: Average, population, and individual approaches to establishing bioequivalence
    • Food and Drug Administration Center for Drug Evaluation and Research. August 1999. Available at: Accessed June 4
    • Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: average, population, and individual approaches to establishing bioequivalence. August 1999. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/3657gdl.pdf. Accessed June 4, 2003.
    • (2003)
  • 19
    • 0033862234 scopus 로고    scopus 로고
    • Enhanced bioavailability of azathioprine compared to 6-mercaptopurine therapy in inflammatory bowel disease: Correlation with treatment efficacy
    • Cuffari C, Hunt S, Bayless TM. Enhanced bioavailability of azathioprine compared to 6-mercaptopurine therapy in inflammatory bowel disease: correlation with treatment efficacy. Aliment Pharmacol Ther. 2000;14:1009-1014.
    • (2000) Aliment. Pharmacol. Ther. , vol.14 , pp. 1009-1014
    • Cuffari, C.1    Hunt, S.2    Bayless, T.M.3
  • 20
    • 0035113430 scopus 로고    scopus 로고
    • New developments in the immunosuppressive drug monitoring of cyclosporine, tacrolimus, and azathioprine
    • Armstrong VW, Oellerich M. New developments in the immunosuppressive drug monitoring of cyclosporine, tacrolimus, and azathioprine. Clin Biochemistry. 2001;34:9-16.
    • (2001) Clin. Biochemistry , vol.34 , pp. 9-16
    • Armstrong, V.W.1    Oellerich, M.2
  • 21
    • 0037282538 scopus 로고    scopus 로고
    • Azathioprine and anti-TNFalpha therapies in Crohn's disease: A review of pharmacology, clinical efficacy and safety
    • Arnott IDR, Watts D, Satsangi J. Azathioprine and anti-TNFalpha therapies in Crohn's disease: a review of pharmacology, clinical efficacy and safety. Pharmacological Res. 2003;47:1-10.
    • (2003) Pharmacological. Res. , vol.47 , pp. 1-10
    • Arnott, I.D.R.1    Watts, D.2    Satsangi, J.3
  • 22
    • 0033830262 scopus 로고    scopus 로고
    • Allelic variants of the thiopurine S-methyltransferase deficiency in patients with ulcerative colitis and in healthy controls
    • Corominas H, Domenech M, Gonzalez D, et al. Allelic variants of the thiopurine S-methyltransferase deficiency in patients with ulcerative colitis and in healthy controls. Am J Gastroenterol. 2000;95:2313-2317.
    • (2000) Am. J. Gastroenterol. , vol.95 , pp. 2313-2317
    • Corominas, H.1    Domenech, M.2    Gonzalez, D.3
  • 23
    • 0029790730 scopus 로고    scopus 로고
    • Individualizing therapy with 6-mercaptopurine and 6-thioguanine related to the thiopurine methyltransferase genetic polymorphism
    • Lennard L, Lilleyman JS. Individualizing therapy with 6-mercaptopurine and 6-thioguanine related to the thiopurine methyltransferase genetic polymorphism. Ther Drug Monitoring. 1996;18:328-334.
    • (1996) Ther. Drug Monitoring , vol.18 , pp. 328-334
    • Lennard, L.1    Lilleyman, J.S.2
  • 24
    • 0036009619 scopus 로고    scopus 로고
    • The thiopurine S-methyltransferase gene locus-implications for clinical pharmacogenomics
    • McLeod HL, Siva C. The thiopurine S-methyltransferase gene locus-implications for clinical pharmacogenomics. Pharmacogenomics. 2002; 3:89-98.
    • (2002) Pharmacogenomics , vol.3 , pp. 89-98
    • McLeod, H.L.1    Siva, C.2
  • 25
    • 0035755993 scopus 로고    scopus 로고
    • Recent advances in the pharmacogenomics of thiopurine methyltransferase
    • Coulthard SA, Hall AG. Recent advances in the pharmacogenomics of thiopurine methyltransferase. Pharmacogenomics J. 2001;1:254-261.
    • (2001) Pharmacogenomics J. , vol.1 , pp. 254-261
    • Coulthard, S.A.1    Hall, A.G.2
  • 26
    • 0036851446 scopus 로고    scopus 로고
    • Pharmacogenetics in rheumatology: The prospects and limitations of an emerging field
    • Siva C, Yokoyama WM, McLeod HL. Pharmacogenetics in rheumatology: the prospects and limitations of an emerging field. Rheumatology. 2002;41:1273-1279.
    • (2002) Rheumatology , vol.41 , pp. 1273-1279
    • Siva, C.1    Yokoyama, W.M.2    McLeod, H.L.3
  • 27
    • 0037421584 scopus 로고    scopus 로고
    • Inheritance and drug response
    • Weinshilboum R. Inheritance and drug response. N Engl J Med. 2003;348:529-537.
    • (2003) N. Engl. J. Med. , vol.348 , pp. 529-537
    • Weinshilboum, R.1
  • 28
    • 0036250295 scopus 로고    scopus 로고
    • Pharmacogenetics: Has it reached the clinic?
    • Mar-Apr
    • Schwartz JB. Pharmacogenetics: has it reached the clinic? J Gend Specif Med. 2002 Mar-Apr;5:13-18.
    • (2002) J. Gend. Specif. Med. , vol.5 , pp. 13-18
    • Schwartz, J.B.1
  • 30
    • 0033771907 scopus 로고    scopus 로고
    • Genomic structure and multiple single-nucleotide polymorphisms (SNPs) of the thiopurine S-methyltransferase (TPMT) gene
    • Seki T, Tanaka T, Nakamura Y. Genomic structure and multiple single-nucleotide polymorphisms (SNPs) of the thiopurine S-methyltransferase (TPMT) gene. J Hum Genet. 2000;45:299-302.
    • (2000) J. Hum. Genet. , vol.45 , pp. 299-302
    • Seki, T.1    Tanaka, T.2    Nakamura, Y.3
  • 31
    • 0027401302 scopus 로고
    • Azathioprine-induced myelosuppression in thiopurine methyltransferase deficient heart transplant recipient
    • Schutz E, Gummert J, Mohr F, Oellerich M. Azathioprine-induced myelosuppression in thiopurine methyltransferase deficient heart transplant recipient. Lancet. 1993;341:436.
    • (1993) Lancet , vol.341 , pp. 436
    • Schutz, E.1    Gummert, J.2    Mohr, F.3    Oellerich, M.4
  • 32
    • 0030871031 scopus 로고    scopus 로고
    • Azathioprine-induced severe pancytopenia due to a homozygous two-point mutation of the thiopurine methyltransferase gene in a patient with juvenile HLA-B-27-associated spondylarthritis
    • Leipold G, Schutz E, Haas JP, Oellerich M. Azathioprine-induced severe pancytopenia due to a homozygous two-point mutation of the thiopurine methyltransferase gene in a patient with juvenile HLA-B-27-associated spondylarthritis. Arthritis Rheum. 1997;40:1896-1898.
    • (1997) Arthritis Rheum. , vol.40 , pp. 1896-1898
    • Leipold, G.1    Schutz, E.2    Haas, J.P.3    Oellerich, M.4
  • 33
    • 0029953165 scopus 로고    scopus 로고
    • Should 6-thioguanine nucleotides be monitored in heart transplant recipients given azathioprine?
    • Schutz E, Gummert J, Mohr FW, et al. Should 6-thioguanine nucleotides be monitored in heart transplant recipients given azathioprine? Ther Drug Monit. 1996;18:228-233.
    • (1996) Ther. Drug Monit. , vol.18 , pp. 228-233
    • Schutz, E.1    Gummert, J.2    Mohr, F.W.3
  • 34
    • 0024451147 scopus 로고
    • Pharmacogenetics of acute azathioprine toxicity: Relationship to thiopurine methyltransferase genetic polymorphism
    • Lennard L, Van Loon JA, Weinshilboum RM. Pharmacogenetics of acute azathioprine toxicity: relationship to thiopurine methyltransferase genetic polymorphism. Clin Phamacol Ther. 1989;46:149-154.
    • (1989) Clin. Phamacol. Ther. , vol.46 , pp. 149-154
    • Lennard, L.1    Van Loon, J.A.2    Weinshilboum, R.M.3
  • 35
    • 0032921854 scopus 로고    scopus 로고
    • Methylation pharmacogenetics: Catechol O-methyltransferase, thiopurine methyltransferase, and histamine N-methyltransferase
    • Weinshilboum RM, Otterness DM, Szumlanski CL. Methylation pharmacogenetics: catechol O-methyltransferase, thiopurine methyltransferase, and histamine N-methyltransferase. Annu Rev Pharmacol Toxicol. 1999;39:19-52.
    • (1999) Annu. Rev. Pharmacol. Toxicol. , vol.39 , pp. 19-52
    • Weinshilboum, R.M.1    Otterness, D.M.2    Szumlanski, C.L.3
  • 36
    • 0023119219 scopus 로고
    • Thiopurine pharmacogenetics in leukemia: Correlation of erythrocyte thiopurine methyltransferase activity and 6-thioguanine nucleotide concentrations
    • Lennard L, Van Loon JA, Lilleyman SJ, Weinshilboum RM. Thiopurine pharmacogenetics in leukemia: correlation of erythrocyte thiopurine methyltransferase activity and 6-thioguanine nucleotide concentrations. Clin Pharmacol Ther. 1987;41:18-25.
    • (1987) Clin. Pharmacol. Ther. , vol.41 , pp. 18-25
    • Lennard, L.1    Van Loon, J.A.2    Lilleyman, S.J.3    Weinshilboum, R.M.4
  • 37
    • 0028843101 scopus 로고
    • The role of genetic variation in thiopurine methyltransferase activity and the efficacy and/or side effects of azathioprine therapy in dermatologic patients
    • Snow JL, Gibson LE. The role of genetic variation in thiopurine methyltransferase activity and the efficacy and/or side effects of azathioprine therapy in dermatologic patients. Arch Dermatol. 1995;131:193-197.
    • (1995) Arch. Dermatol. , vol.131 , pp. 193-197
    • Snow, J.L.1    Gibson, L.E.2
  • 38
    • 0038294345 scopus 로고    scopus 로고
    • Pharmacogenetics of drug metabolizing enzymes: Importance for personalized medicine
    • Oscarson M. Pharmacogenetics of drug metabolizing enzymes: importance for personalized medicine. Clin Chem Lab Med. 2003; 41:573-580.
    • (2003) Clin. Chem. Lab. Med. , vol.41 , pp. 573-580
    • Oscarson, M.1
  • 39
    • 0025331198 scopus 로고
    • Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukaemia
    • Lennard L, Lilleyman JS, Van Loon J, Weinshilboum RM. Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukaemia. Lancet. 1990; 336:225-229.
    • (1990) Lancet , vol.336 , pp. 225-229
    • Lennard, L.1    Lilleyman, J.S.2    Van Loon, J.3    Weinshilboum, R.M.4
  • 40
    • 0027232125 scopus 로고
    • Fast and slow methylators: Do racial differences influence risk of allograft rejection?
    • Chocair PR, Duley JA, Sabbaga E, et al. Fast and slow methylators: do racial differences influence risk of allograft rejection? Quarterly J Med. 1993;86:359-363.
    • (1993) Quarterly J. Med. , vol.86 , pp. 359-363
    • Chocair, P.R.1    Duley, J.A.2    Sabbaga, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.