메뉴 건너뛰기




Volumn 51, Issue 6, 2010, Pages 941-950

Generic products of antiepileptic drugs: A perspective on bioequivalence and interchangeability

Author keywords

Average bioequivalence; Generic products of antiepileptic drugs; Interchangeability; Prescribability; Scaled average bioequivalence; Switchability

Indexed keywords

ANTICONVULSIVE AGENT; GENERIC DRUG;

EID: 77954627471     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2010.02573.x     Document Type: Review
Times cited : (58)

References (58)
  • 2
    • 77954646912 scopus 로고    scopus 로고
    • Featured Report; Last Accessed May 1, 2009
    • American Medical Association. (2002) Featured Report; Generic Drugs (A-02). http://www.ama.-assn.org/ama/pub/category/print/15279.html Last Accessed May 1, 2009.
    • (2002) Generic Drugs (A-02)
  • 3
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutics drug classification: The correction of in vitro drug product dissolution and in vivo bioavailability
    • Amidon GL, Lennernas H, Shah VP, Crison JR. (1995) A theoretical basis for a biopharmaceutics drug classification: the correction of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413-420.
    • (1995) Pharm Res , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4
  • 4
    • 33847629307 scopus 로고    scopus 로고
    • Compulsory generic switching of antiepileptic drugs: High switchback rates to branded compounds compared with other drug classes
    • DOI 10.1111/j.1528-1167.2007.01007.x
    • Andermann F, Duh MS, Gosselin A, Paradis PE. (2007) Compulsory generic switching of antiepileptic drugs; high switchback rates to branded compounds compared with other drug classes. Epilepsia 48:464-469. (Pubitemid 46365174)
    • (2007) Epilepsia , vol.48 , Issue.3 , pp. 464-469
    • Andermann, F.1    Duh, M.S.2    Gosselin, A.3    Paradis, P.E.4
  • 5
    • 42049090602 scopus 로고    scopus 로고
    • Pharmacokinetic, pharmacodynamic and pharmacogenetic targeted therapy of antiepileptic drugs
    • Anderson GD. (2008) Pharmacokinetic, pharmacodynamic and pharmacogenetic targeted therapy of antiepileptic drugs. Ther Drug Monit 30:173-180.
    • (2008) Ther Drug Monit , vol.30 , pp. 173-180
    • Anderson, G.D.1
  • 6
    • 0032444519 scopus 로고    scopus 로고
    • Generic substitution of NTI drugs: Issues for formulary committee consideration
    • Banahan BF, Bonnarens JK, Bentley JP. (1998) Generic substitution of NTI drugs: issues for formulary committee consideration. Formulary 33:1082-1096.
    • (1998) Formulary , vol.33 , pp. 1082-1096
    • Banahan, B.F.1    Bonnarens, J.K.2    Bentley, J.P.3
  • 7
    • 0029026110 scopus 로고
    • Bioequivalence and narrow therapeutic index drugs
    • Benet LZ, Goyan JE. (1995) Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 15:433-440.
    • (1995) Pharmacotherapy , vol.15 , pp. 433-440
    • Benet, L.Z.1    Goyan, J.E.2
  • 9
    • 34247223819 scopus 로고    scopus 로고
    • What's the problem with generic antiepileptic drugs?
    • Berg MJ. (2007) What's the problem with generic antiepileptic drugs? Neurology 68:1245-1246.
    • (2007) Neurology , vol.68 , pp. 1245-1246
    • Berg, M.J.1
  • 11
    • 50449089898 scopus 로고    scopus 로고
    • Generic substitution in the treatment of epilepsy: Case evidence of breakthrough seizures
    • Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS. (2008b) Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology 71:525-530.
    • (2008) Neurology , vol.71 , pp. 525-530
    • Berg, M.J.1    Gross, R.A.2    Tomaszewski, K.J.3    Zingaro, W.M.4    Haskins, L.S.5
  • 12
    • 0026584229 scopus 로고
    • Pharmacokinetic evaluation of sustained release formulations of antiepileptic drugs
    • Bialer M. (1992) Pharmacokinetic evaluation of sustained release formulations of antiepileptic drugs. Clin Pharmacokinet 22:11-22.
    • (1992) Clin Pharmacokinet , vol.22 , pp. 11-22
    • Bialer, M.1
  • 13
    • 0031935126 scopus 로고    scopus 로고
    • Does carbamazepine have a narrow therapeutic plasma concentration range?
    • Bialer M, Levy RH, Perucca E. (1998) Does carbamazepine have a narrow therapeutic plasma concentration range? Ther Drug Monit 20:56-59.
    • (1998) Ther Drug Monit , vol.20 , pp. 56-59
    • Bialer, M.1    Levy, R.H.2    Perucca, E.3
  • 14
    • 35148836175 scopus 로고    scopus 로고
    • Generic products of antiepileptic drugs (AEDs): Is it an issue?
    • Bialer M. (2007) Generic products of antiepileptic drugs (AEDs): is it an issue? Epilepsia 48:1825-1832.
    • (2007) Epilepsia , vol.48 , pp. 1825-1832
    • Bialer, M.1
  • 15
    • 0027141414 scopus 로고
    • Bio-International 1992, Conference on bioavailability, bioequivalence, and pharmacokinetic studies
    • Blume HH, Midha KK. (1993) Bio-International 1992, Conference on bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci: 82:1186-1189
    • (1993) J Pharm Sci , vol.82 , pp. 1186-1189
    • Blume, H.H.1    Midha, K.K.2
  • 16
    • 77954641436 scopus 로고    scopus 로고
    • and Pharm Res 10: 1806-1811.
    • Pharm Res , vol.10 , pp. 1806-1811
  • 18
    • 0034764371 scopus 로고    scopus 로고
    • Individual bioequivalence revisited
    • Chen M-L, Lesko LK. (2001) Individual bioequivalence revisited. Clin Pharmacokinet 40:701-706.
    • (2001) Clin Pharmacokinet , vol.40 , pp. 701-706
    • Chen, M.-L.1    Lesko, L.K.2
  • 19
    • 62649128592 scopus 로고    scopus 로고
    • The use of drug metabolism for predicting intestinal permeability
    • Chen M-L, Yu L. (2009) The use of drug metabolism for predicting intestinal permeability. Mol Pharm 6:74-81.
    • (2009) Mol Pharm , vol.6 , pp. 74-81
    • Chen, M.-L.1    Yu, L.2
  • 20
    • 77954629576 scopus 로고    scopus 로고
    • Evaluating FDA bioequivalence standards for generic carbamazepine formulations
    • Chuang K, Krauss GL, Cao YJ. (2009) Evaluating FDA bioequivalence standards for generic carbamazepine formulations. Neurology, 72:A226.
    • (2009) Neurology , vol.72
    • Chuang, K.1    Krauss, G.L.2    Cao, Y.J.3
  • 21
    • 33645034556 scopus 로고    scopus 로고
    • Are there potential problems with generic substitution of antiepileptic drug:? A review of issues
    • Crawford P, Feely M, Guberman A, Kramer G. (2006) Are there potential problems with generic substitution of antiepileptic drug:? a review of issues Seizure 15:165-176.
    • (2006) Seizure , vol.15 , pp. 165-176
    • Crawford, P.1    Feely, M.2    Guberman, A.3    Kramer, G.4
  • 24
    • 0032189788 scopus 로고    scopus 로고
    • Individual bioequivalence- has it time come?
    • Endrenyi L, Midha KK. (1998) Individual bioequivalence- has it time come? European J. Pharm Sci 6:271-277.
    • (1998) European J. Pharm Sci , vol.6 , pp. 271-277
    • Endrenyi, L.1    Midha, K.K.2
  • 25
    • 0031721971 scopus 로고    scopus 로고
    • Individual bioequivalence; Attractive in principle, difficult in practice
    • Endrenyi L, Amidon GL, Midha KK, Skelly JP. (1998) Individual bioequivalence; Attractive in principle, difficult in practice. Pharm Res 15:1321-1325.
    • (1998) Pharm Res , vol.15 , pp. 1321-1325
    • Endrenyi, L.1    Amidon, G.L.2    Midha, K.K.3    Skelly, J.P.4
  • 26
    • 77954631030 scopus 로고    scopus 로고
    • October 29, 2002. Available at: Accessed January 28 2009
    • FDA. (2002) Process for Approving Generic Drugs. October 29, 2002. Available at: http:/http://www.fda.gov/cder/ogd-10-BCBS-gjb, Accessed January 28 2009.
    • (2002) Process for Approving Generic Drugs
  • 29
    • 0031092047 scopus 로고    scopus 로고
    • Commentary on individual bioequivalence by M-L Chen
    • Hauck WW, Anderson S. (1997) Commentary on individual bioequivalence by M-L Chen. J Biopharm Stat 7:13-16.
    • (1997) J Biopharm Stat , vol.7 , pp. 13-16
    • Hauck, W.W.1    Anderson, S.2
  • 30
    • 85136438639 scopus 로고    scopus 로고
    • Review of generic bioequivalence studies
    • Henney JE. (1999) Review of generic bioequivalence studies. JAMA 282:1995-1995.
    • (1999) JAMA , vol.282 , pp. 1995-1995
    • Henney, J.E.1
  • 31
    • 4344592086 scopus 로고    scopus 로고
    • Prescribing antiepileptic drugs: Should patients be switched on the basis of cost?
    • Jobst BC, Holmes GL. (2004) Prescribing antiepileptic drugs: should patients be switched on the basis of cost? CNS Drugs 18:617-628.
    • (2004) CNS Drugs , vol.18 , pp. 617-628
    • Jobst, B.C.1    Holmes, G.L.2
  • 33
    • 0036226944 scopus 로고    scopus 로고
    • Risken der neuen Aut-idem-Regelung fur die Behandlung mit Antiepileptika
    • Ad-hoc-Kommission der Deutschen Sekton der Internationalen Liga Gegen Epilepsie
    • Kramer G, Schneble H, Wolf P; Ad-hoc-Kommission der Deutschen Sekton der Internationalen Liga Gegen Epilepsie. (2002) Risken der neuen Aut-idem-Regelung fur die Behandlung mit Antiepileptika. Akt Neuerol 29:115-122.
    • (2002) Akt Neuerol , vol.29 , pp. 115-122
    • Kramer, G.1    Schneble, H.2    Wolf, P.3
  • 34
    • 33847627126 scopus 로고    scopus 로고
    • Experience with generic drugs in epilepsy patients: An electronic survey of members of the German, Austrian and Swiss Branches of the ILAE
    • Kramer G, Steinhoff BJ, Feucht M, Pfafflin M, May TW. (2007) Experience with generic drugs in epilepsy patients: an electronic survey of members of the German, Austrian and Swiss Branches of the ILAE. Epilepsia; 48:609-611.
    • (2007) Epilepsia , vol.48 , pp. 609-611
    • Kramer, G.1    Steinhoff, B.J.2    Feucht, M.3    Pfafflin, M.4    May, T.W.5
  • 35
    • 0035964225 scopus 로고    scopus 로고
    • Buy some today: Can generic be safely substituted for brand-name drugs?
    • Lesser RP, Krauss G. (2001) Buy some today: can generic be safely substituted for brand-name drugs? Neurology 57:571-573.
    • (2001) Neurology , vol.57 , pp. 571-573
    • Lesser, R.P.1    Krauss, G.2
  • 37
    • 34247244258 scopus 로고    scopus 로고
    • Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy
    • DOI 10.1212/01.wnl.0000259400.30539.cc, PII 0000611420070417000005
    • Liow K, Barkley GL, Pollard JR, Harden CL, Bazil CW. (2007) Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology 68:1249-1250. (Pubitemid 46625968)
    • (2007) Neurology , vol.68 , Issue.16 , pp. 1249-1250
    • Liow, K.1    Barkley, G.L.2    Pollard, J.R.3    Harden, C.L.4    Bazil, C.W.5
  • 38
    • 0030692734 scopus 로고    scopus 로고
    • Individual and average bioequivalence of highly variable drugs and drug products
    • Midha KK, Rawson MJ, Hubbard JW. (1997) Individual and average bioequivalence of highly variable drugs and drug products. J Pharm Sci 86:1193-1197.
    • (1997) J Pharm Sci , vol.86 , pp. 1193-1197
    • Midha, K.K.1    Rawson, M.J.2    Hubbard, J.W.3
  • 39
  • 40
    • 72949113750 scopus 로고    scopus 로고
    • Bioequivalence measures and parameters, criteria for comparisons, ABE and IBE
    • Amidon G, Lesko L, Midha KK, Shah V, Hilfinger J, (Eds) TSRL Inc., Ann Arbor
    • Midha KK, Rawson MJ, Hubbard JW. (2006) Bioequivalence measures and parameters, criteria for comparisons, ABE and IBE. In: Amidon G, Lesko L, Midha KK, Shah V, Hilfinger J, (Eds) International bioequivalence standards: a new era., TSRL Inc., Ann Arbor; pp. 147-160.
    • (2006) International Bioequivalence Standards: A New Era , pp. 147-160
    • Midha, K.K.1    Rawson, M.J.2    Hubbard, J.W.3
  • 42
    • 0023644115 scopus 로고
    • Generic drugs and prescribing physician
    • Nightingale SL, Morrsion JC. (1987) Generic drugs and prescribing physician. JAMA 258:1200-1204.
    • (1987) JAMA , vol.258 , pp. 1200-1204
    • Nightingale, S.L.1    Morrsion, J.C.2
  • 44
    • 45749150011 scopus 로고    scopus 로고
    • Antiepileptic drugs - Best practice guidance for therapeutic drug monitoring: A position paper by the subcommission on therapeutic drug monitoring
    • ILAE Commission on Therapeutic Strategies
    • Patsalos PN, Berry DJ, Bourgeois BF, Cloyd JC, Glauser TA, Johannessen SI, Leppik IE, Tomson T, Perucca E. (2008) Antiepileptic drugs - best practice guidance for therapeutic drug monitoring: a position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia 49:1239-1276.
    • (2008) Epilepsia , vol.49 , pp. 1239-1276
    • Patsalos, P.N.1    Berry, D.J.2    Bourgeois, B.F.3    Cloyd, J.C.4    Glauser, T.A.5    Johannessen, S.I.6    Leppik, I.E.7    Tomson, T.8    Perucca, E.9
  • 45
    • 33845527149 scopus 로고    scopus 로고
    • Recommendation of the Italian League Against Epilepsy Working Group on Generic Products of Antiepileptic Drugs
    • Perucca E, Albani F, Capovilla G, Dalla Bernardina B, Michelucci R, Zaccara G. (2006) Recommendation of the Italian League Against Epilepsy Working Group on Generic Products of Antiepileptic Drugs. Epilepsia 47(Suppl. 5):16-20.
    • (2006) Epilepsia , vol.47 , Issue.SUPPL. 5 , pp. 16-20
    • Perucca, E.1    Albani, F.2    Capovilla, G.3    Dalla Bernardina, B.4    Michelucci, R.5    Zaccara, G.6
  • 46
    • 64049107397 scopus 로고    scopus 로고
    • Generic antiepileptic drugs: Current controversies and future directions
    • Privitera MD. (2008) Generic antiepileptic drugs: current controversies and future directions. Epilepsy Curr. 8:113-117.
    • (2008) Epilepsy Curr. , vol.8 , pp. 113-117
    • Privitera, M.D.1
  • 48
    • 77949995036 scopus 로고    scopus 로고
    • Industry fights switch to generics for epilepsy
    • Rubinstein S. (2007) Industry fights switch to generics for epilepsy. Wall Street J 13:A1-A10.
    • (2007) Wall Street J , vol.13
    • Rubinstein, S.1
  • 49
    • 0023615056 scopus 로고
    • A comparison of the two-one-sided tests procedure and the power approach for assessing equivalence of average bioavailability
    • Schuirmann DJ. (1987) A comparison of the two-one-sided tests procedure and the power approach for assessing equivalence of average bioavailability. J Pharmacokinet Biopharm 18:657-680.
    • (1987) J Pharmacokinet Biopharm , vol.18 , pp. 657-680
    • Schuirmann, D.J.1
  • 50
    • 33846176619 scopus 로고    scopus 로고
    • A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan
    • DOI 10.1021/mp0600182
    • Takagi T, Ramachandran C, Bermejo M, Yamashita S, Yu LX, Amidon G. (2006) A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain and Japan. Mol Pharm 3:631-643. (Pubitemid 46087480)
    • (2006) Molecular Pharmaceutics , vol.3 , Issue.6 , pp. 631-643
    • Takagi, T.1    Ramachandran, C.2    Bermejo, M.3    Yamashita, S.4    Yu, L.X.5    Amidon, G.L.6
  • 51
    • 77954633311 scopus 로고    scopus 로고
    • Therapeutic equivalence of generic drugs response to national association of boards of pharmacy
    • April 16, 1997
    • Williams RL. (1997) Therapeutic equivalence of generic drugs response to national association of boards of pharmacy. FDA, CEDAR, April 16, 1997.
    • (1997) FDA, CEDAR
    • Williams, R.L.1
  • 53
    • 0041383894 scopus 로고    scopus 로고
    • Physicians underestimate the frequency of generic carbamazepine substitution: Results of a survey and review of the problem
    • Wilner AN. (2002) Physicians underestimate the frequency of generic carbamazepine substitution: results of a survey and review of the problem. Epilepsy Behav 3:522-525.
    • (2002) Epilepsy Behav , vol.3 , pp. 522-525
    • Wilner, A.N.1
  • 54
    • 10844260714 scopus 로고    scopus 로고
    • Therapeutic equivalency of generic antiepileptic drugs: Results of a survey
    • Wilner AN. (2004) Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav 5:995-998.
    • (2004) Epilepsy Behav , vol.5 , pp. 995-998
    • Wilner, A.N.1
  • 56
    • 42049122567 scopus 로고    scopus 로고
    • Should newly diagnosed epilepsy be treated with generics?
    • Wolf P. (2008) Should newly diagnosed epilepsy be treated with generics? Nature Clin Pract 4:176-177.
    • (2008) Nature Clin Pract , vol.4 , pp. 176-177
    • Wolf, P.1
  • 57
    • 17644380257 scopus 로고    scopus 로고
    • Predicting drug disposition via application of BCS: Transport/absorption elimination interplay and development of biopharmaceutics drug disposition classification system
    • Wu C-Y, Benet LZ. (2005) Predicting drug disposition via application of BCS: transport/absorption elimination interplay and development of biopharmaceutics drug disposition classification system. Pharm Res 22:11-23.
    • (2005) Pharm Res , vol.22 , pp. 11-23
    • Wu, C.-Y.1    Benet, L.Z.2
  • 58
    • 61849112140 scopus 로고    scopus 로고
    • Case-control analysis of ambulance, emergency room, or in inpatient hospital events for epilepsy and antiepileptic drug formulation changes
    • Zachry WM III, Quynhchau DD, Clewell JD, Smith BJ. (2009) Case-control analysis of ambulance, emergency room, or in inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 50:493-500.
    • (2009) Epilepsia , vol.50 , pp. 493-500
    • Zachry III, W.M.1    Quynhchau, D.D.2    Clewell, J.D.3    Smith, B.J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.