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Volumn 59, Issue 4, 2009, Pages 155-165

Considerations for metabolite pharmacokinetic data in bioavailability/ bioequivalence assessments: Overview of the recent trends

Author keywords

Bioavailability, assessments; Bioequivalence, assessments; Metabolites, pharmacokinetic data; Parent compounds, bioavailability, bioequivalence

Indexed keywords

4 ACETAMIDO 5 AMINO 3 (1 ETHYLPROPOXY) 1 CYCLOHEXENE 1 CARBOXYLIC ACID; 6 METHOXY 2 NAPHTHYLACETIC ACID; APOVINCAMINIC ACID; ATORVASTATIN; CARENONE; CLOPIDOGREL; DEACETYLDILTIAZEM; DESLORATADINE; DESVENLAFAXINE; DILTIAZEM; DIURETIC AGENT; DRUG METABOLITE; ERLOTINIB; LICARBAZEPINE; LORATADINE; LOSARTAN; MECLOFENOXATE; METRONIDAZOLE; MEVINOLIN; N NORDILTIAZEM; NABUMETONE; OSELTAMIVIR; OXCARBAZEPINE; QUINAPRIL; QUINAPRILAT; SPIRONOLACTONE; TRIFLUSAL; UNCLASSIFIED DRUG; UNINDEXED DRUG; VENLAFAXINE; VINPOCETINE;

EID: 66149168383     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296380     Document Type: Review
Times cited : (9)

References (47)
  • 2
    • 0033663490 scopus 로고    scopus 로고
    • Bioavailability and bioequivalence: Average, population and/or individual
    • Colburn WA, Keefe DL. Bioavailability and bioequivalence: average, population and/or individual. J Clin Pharmacol. 2000;40:559-560.
    • (2000) J Clin Pharmacol , vol.40 , pp. 559-560
    • Colburn, W.A.1    Keefe, D.L.2
  • 3
    • 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, Ganes D, Lapointe C, Abolfathi Z, 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    Ganes, D.4    Lapointe, C.5    Abolfathi, Z.6
  • 4
    • 0031795947 scopus 로고    scopus 로고
    • The phenytoin trial is a case study of 'individual' bioequivalence
    • Schumaker RC, Metzler CM. The phenytoin trial is a case study of individual bioequivalence. Drug Inf J . 1998;32:1063-1072. (Pubitemid 28531395)
    • (1998) Drug Information Journal , vol.32 , Issue.4 , pp. 1063-1072
    • Shumaker, R.C.1    Metzler, C.M.2
  • 5
    • 0034921142 scopus 로고    scopus 로고
    • Population and individual bioequivalence: Lessons from real data and simulation studies
    • DOI 10.1177/00912700122010708
    • Zariffa NM, Patterson SD. Population and individual bioequivalence: lessons from real data and simulation studies. J Clin Pharmacol. 2001;41:811-822. (Pubitemid 32692091)
    • (2001) Journal of Clinical Pharmacology , vol.41 , Issue.8 , pp. 811-822
    • Zariffa, N.M.-D.1    Patterson, S.D.2
  • 7
    • 1642494655 scopus 로고    scopus 로고
    • Role of stereoselective assays in bioequivalence studies of racemic drugs: Have we reached a consensus?
    • Srinivas NR. Role of stereoselective assays in bioequivalence studies of racemic drugs: have we reached a consensus? J Clin Pharmacol. 2004;44:115-119.
    • (2004) J Clin Pharmacol , vol.44 , pp. 115-119
    • Srinivas, N.R.1
  • 8
    • 0030851895 scopus 로고    scopus 로고
    • Bioequivalence of chiral drugs. Stereospecific versus non-stereospecific methods
    • Mehvar R, Jamali F. Bioequivalence of chiral drugs. Stereospecific versus non-stereospecific methods. Clin Pharmacokin. 1997;33:122-141.
    • (1997) Clin Pharmacokin , vol.33 , pp. 122-141
    • Mehvar, R.1    Jamali, F.2
  • 11
    • 3242772217 scopus 로고    scopus 로고
    • Metabolites and bioequivalence. Past and present
    • Jackson AJ, Robbie G, Marroum P. Metabolites and bioequivalence. Past and present. Clin Pharmacokin. 2004;43:655-672.
    • (2004) Clin Pharmacokin , vol.43 , pp. 655-672
    • Jackson, A.J.1    Robbie, G.2    Marroum, P.3
  • 12
    • 4344678870 scopus 로고    scopus 로고
    • The role of metabolites in bioequivalence
    • DOI 10.1023/B:PHAM.0000036906.65263.da
    • Midha KK, Rawson MJ, Hubbard JW. The role of metabolites in bioequivalence. PharmRes . 2004;21:1331-1344. (Pubitemid 39149647)
    • (2004) Pharmaceutical Research , vol.21 , Issue.8 , pp. 1331-1344
    • Midha, K.K.1    Rawson, M.J.2    Hubbard, J.W.3
  • 13
    • 0003478656 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products, Committee for Products, Committee for proprietary medicinal products. CPMP/EWP/QWP/1401/ 98, London, 26 July
    • The European Agency for the Evaluation of Medicinal Products, Committee for Products, Committee for proprietary medicinal products. Note for guidance on the investigation of bioavailability/bioequivalence. CPMP/EWP/QWP/1401/98, London, 26 July 2001.
    • (2001) Note for Guidance on the Investigation of Bioavailability/bioequivalence
  • 16
    • 53049106926 scopus 로고    scopus 로고
    • Bioequivalence and pharmacokinetic comparison of a single 200 mg dose of meclofenoxate hydrochloride capsule and tablet formulations in healthy Chinese adult male volunteers: A randomized sequence, open-label, two-period crossover study
    • Zou JJ, Ji HJ, Wu DW, Yao J, Hu Q, Xiao DW, et al. Bioequivalence and pharmacokinetic comparison of a single 200 mg dose of meclofenoxate hydrochloride capsule and tablet formulations in healthy Chinese adult male volunteers: a randomized sequence, open-label, two-period crossover study. Clin Ther . 2008;30:1651-1657.
    • (2008) Clin Ther , vol.30 , pp. 1651-1657
    • Zou, J.J.1    Ji, H.J.2    Wu, D.W.3    Yao, J.4    Hu, Q.5    Xiao, D.W.6
  • 17
    • 41849139699 scopus 로고    scopus 로고
    • Bioequivalence assessment of two formulations of spironolactone in Chinese healthy male volunteers
    • Xu FG, Zhang ZJ, Dong HJ, Tian Y, Liu Y, Chen Y. Bioequivalence assessment of two formulations of spironolactone in Chinese healthy male volunteers. Arzneimittelforschung. 2008;58:117-121.
    • (2008) Arzneimittelforschung , vol.58 , pp. 117-121
    • Xu, F.G.1    Zhang, Z.J.2    Dong, H.J.3    Tian, Y.4    Liu, Y.5    Chen, Y.6
  • 18
    • 39749124833 scopus 로고    scopus 로고
    • Pharmacokinetics and bioequivalence study of two tablet formulations of lovastatin in healthy volunteers
    • Mignini F, Tomassoni D, Streccioni V, Traini E, Amenta F. Pharmacokinetics and bioequivalence study of two tablet formulations of lovastatin in healthy volunteers. Clin Exp Hypertens. 2008;30:95-108.
    • (2008) Clin Exp Hypertens , vol.30 , pp. 95-108
    • Mignini, F.1    Tomassoni, D.2    Streccioni, V.3    Traini, E.4    Amenta, F.5
  • 19
    • 44649146524 scopus 로고    scopus 로고
    • Pharmacokinetics and bioequivalence study of the two 20-mg quinapril hydrochloride tablet formulations in healthy Thai male volunteers
    • Rojanasthien N, Nasangiam N, Kumsorn B, Roongapinun S, Jengjareon A. Pharmacokinetics and bioequivalence study of the two 20-mg quinapril hydrochloride tablet formulations in healthy Thai male volunteers. J Med Assoc Thai. 2008;91:739-746
    • (2008) J Med Assoc Thai , vol.91 , pp. 739-746
    • Rojanasthien, N.1    Nasangiam, N.2    Kumsorn, B.3    Roongapinun, S.4    Jengjareon, A.5
  • 20
    • 40849101442 scopus 로고    scopus 로고
    • High-performance liquid chromatographic determination of inactive carboxylic acid metabolite of clopidogrel in human serum: Application to a bioequivalence study
    • Bahrami G, Mohammadi B, Sisakhtnezhad S. High-performance liquid chromatographic determination of inactive carboxylic acid metabolite of clopidogrel in human serum: Application to a bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci . 2008;864:168-172.
    • (2008) J Chromatogr B Analyt Technol Biomed Life Sci , vol.864 , pp. 168-172
    • Bahrami, G.1    Mohammadi, B.2    Sisakhtnezhad, S.3
  • 22
    • 43949120415 scopus 로고    scopus 로고
    • Liquid chromatography tandem mass spectrometry assay for the simultaneous determination of venlafaxine and O-desmethylenlafaxine in human plasma and its application to a bioequivalence study
    • Patel BN, Sharma N, Sanyal M, Shrivastav PS. Liquid chromatography tandem mass spectrometry assay for the simultaneous determination of venlafaxine and O-desmethylenlafaxine in human plasma and its application to a bioequivalence study. J PharmBiomed Anal. 2008a;47: 603-611
    • (2008) J PharmBiomed Anal , vol.47 , pp. 603-611
    • Patel, B.N.1    Sharma, N.2    Sanyal, M.3    Shrivastav, P.S.4
  • 23
    • 65949121371 scopus 로고    scopus 로고
    • High-throughput LC-MS/MS assay for 6-methoxy-2-naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study
    • Patel BN, Sharma N, Sanyal M, Prasad A, Shrivastav PS. High-throughput LC-MS/MS assay for 6-methoxy-2-naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study. Biomed Chromatogr. 2008;22:1213-1224.
    • (2008) Biomed Chromatogr , vol.22 , pp. 1213-1224
    • Patel, B.N.1    Sharma, N.2    Sanyal, M.3    Prasad, A.4    Shrivastav, P.S.5
  • 24
    • 41549134040 scopus 로고    scopus 로고
    • Nonlinear calibrations on the assay of diltiazem and two of its metabolites from plasma samples by means of liquid chromatography and ESI/MS2 detection: Application to a bioequivalence study
    • Georgita C, Albu F, David, V, Medvedovici A. Nonlinear calibrations on the assay of diltiazem and two of its metabolites from plasma samples by means of liquid chromatography and ESI/MS2 detection: Application to a bioequivalence study. Biomed Chromatogr . 2008;22:289-297.
    • (2008) Biomed Chromatogr , vol.22 , pp. 289-297
    • Georgita, C.1    Albu, F.2    David, V.3    Medvedovici, A.4
  • 25
    • 34447513706 scopus 로고    scopus 로고
    • Parent drug and/or metabolite? Which of them is most appropriate to establish bioequivalence of two oral oxcarbazepine formulations in healthy volunteers?
    • Di Girolamo G, Opezzo JA, Schere D, Gonzalez CD, Moncalvo JJ. Parent drug and/or metabolite? Which of them is most appropriate to establish bioequivalence of two oral oxcarbazepine formulations in healthy volunteers? Expert Opin Pharmacother. 2007;8:1415-1423.
    • (2007) Expert Opin Pharmacother , vol.8 , pp. 1415-1423
    • Di Girolamo, G.1    Opezzo, J.A.2    Schere, D.3    Gonzalez, C.D.4    Moncalvo, J.J.5
  • 26
    • 34848832055 scopus 로고    scopus 로고
    • Validated ion pair liquid chromatography/fluorescence detection method for assessing the variability of the loratadine metabolism occurring in bioequivalence studies
    • DOI 10.1002/bmc.845
    • Sora DL, Udrescu S, David V, Medvedovici A. Validated ion pair liquid chromatography/fluorescence detection method for assessing the variability of the loratadine metabolism occurring in bioequivalence studies. Biomed Chromatogr. 2007;21:1023-1029. (Pubitemid 47490312)
    • (2007) Biomedical Chromatography , vol.21 , Issue.10 , pp. 1023-1029
    • Sora, D.I.1    Udrescu, S.2    David, V.3    Medvedovici, A.4
  • 30
    • 32944469063 scopus 로고    scopus 로고
    • Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects
    • DOI 10.1177/0091270005284193
    • Frohna P, Lu J, Eppler S, Hamilton M, Wolf J, Rakhit A, et al. Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects. J Clin Pharmacol. 2006;46:282-290. (Pubitemid 43260315)
    • (2006) Journal of Clinical Pharmacology , vol.46 , Issue.3 , pp. 282-290
    • Frohna, P.1    Lu, J.2    Eppler, S.3    Hamilton, M.4    Wolf, J.5    Rakhit, A.6    Ling, J.7    Kenkare-Mitra, S.R.8    Lum, B.L.9
  • 31
    • 33846302037 scopus 로고    scopus 로고
    • Active metabolite from Tamiflu solution is bioequivalent to that from capsule delivery in healthy volunteers: A cross-over, randomized, open-label study
    • Brewster M, Smith JR, Dutkowski R, Robson R. Active metabolite from Tamiflu solution is bioequivalent to that from capsule delivery in healthy volunteers: A cross-over, randomized, open-label study. Vaccine 2006;24:44-46.
    • (2006) Vaccine , vol.24 , pp. 44-46
    • Brewster, M.1    Smith, J.R.2    Dutkowski, R.3    Robson, R.4
  • 32
    • 33748942492 scopus 로고    scopus 로고
    • Simultaneous quantification of atorvastatin and active metabolites in human plasma by liquid chromatography-tandem mass spectrometry using rosuvastatin as internal standard
    • DOI 10.1002/bmc.622
    • Nirogi RV, Kandikere VN, Shukla M, Mudigonda K, Maurya S, Boosi R, et al. Simultaneous quantification of atorvastatin and active metabolites in human plasma by liquid chromatography-tandem mass spectrometry using rosuvastatin as internal standard. Biomed Chromatogr. 2006;20:924-936. (Pubitemid 44430552)
    • (2006) Biomedical Chromatography , vol.20 , Issue.9 , pp. 924-936
    • Nirogi, R.V.S.1    Kandikere, V.N.2    Shukla, M.3    Mudigonda, K.4    Maurya, S.5    Boosi, R.6    Anjaneyulu, Y.7
  • 33
    • 33749010072 scopus 로고    scopus 로고
    • Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers
    • Mendoza L, Hajduch M, Plausinaitu R, Platilova V, Emritte N, Svoboda M. Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers. Pharmazie. 2006;61:805-806 (Pubitemid 44450376)
    • (2006) Pharmazie , vol.61 , Issue.9 , pp. 805-806
    • Mendoza, L.1    Hajduch, M.2    Plausinaitis, R.3    Platilova, V.4    Emritte, N.5    Svoboda, M.6
  • 34
    • 28744432574 scopus 로고    scopus 로고
    • Pharmacokinetics and comparative bioavailability of two vinpocetine tablet formulations in healthy volunteers by using the metabolite apovincaminic acid as pharmacokinetic parameter
    • Vlase L, Bodiu B, Leucuta SE. Pharmacokinetics and comparative bioavailability of two vinpocetine tablet formulations in healthy volunteers by using the metabolite apovincaminic acid as pharmacokinetic parameter. Arzneimittelforschung. 2005;55:664-668. (Pubitemid 41756049)
    • (2005) Arzneimittel-Forschung/Drug Research , vol.55 , Issue.11 , pp. 664-668
    • Vlase, L.1    Bodiu, B.2    Leucuta, S.E.3
  • 36
    • 41549123661 scopus 로고    scopus 로고
    • Changing need for bioanalysis during drug development
    • Srinivas NR. Changing need for bioanalysis during drug development. Biomed Chromatogr. 2008;22:235-243.
    • (2008) Biomed Chromatogr , vol.22 , pp. 235-243
    • Srinivas, N.R.1
  • 37
    • 33646845338 scopus 로고    scopus 로고
    • Applicability of bioanalysis of multiple analytes in drug discovery and development: Review of select case studies including assay development considerations
    • DOI 10.1002/bmc.594
    • Srinivas NR. Applicability of bioanalysis of multiple analytes in drug discovery and development: review of select case studies including assay development considerations. Biomed Chromatogr. 2006;20:383-414. (Pubitemid 43772018)
    • (2006) Biomedical Chromatography , vol.20 , Issue.5 , pp. 383-414
    • Srinivas, N.R.1
  • 38
    • 67649656077 scopus 로고    scopus 로고
    • Dodging matrix effects in liquid chromatography tandem mass spectrometric assays - Compilation of key learnings and perspectives
    • DOI:10.1002/bmc.1152
    • Srinivas NR. Dodging matrix effects in liquid chromatography tandem mass spectrometric assays - Compilation of key learnings and perspectives. Biomed Chromatogr. 2008; DOI:10.1002/bmc.1152.
    • (2008) Biomed Chromatogr
    • Srinivas, N.R.1
  • 40
    • 0348049545 scopus 로고    scopus 로고
    • Ionization enhancement in atmospheric pressure chemical ionization and suppression in electrospray ionization between target drugs and stable-isotope-labeled internal standards in quantitative liquid chromatography/tandem mass spectrometry
    • Liang HR, Foltz RL Meng M, Bennett P. Ionization enhancement in atmospheric pressure chemical ionization and suppression in electrospray ionization between target drugs and stable-isotope-labeled internal standards in quantitative liquid chromatography/tandem mass spectrometry. Rapid Comm Mass Spectrom. 2003;17:2815-2821. (Pubitemid 38029325)
    • (2003) Rapid Communications in Mass Spectrometry , vol.17 , Issue.24 , pp. 2815-2821
    • Liang, H.R.1    Foltz, R.L.2    Meng, M.3    Bennett, P.4
  • 41
    • 0032996183 scopus 로고    scopus 로고
    • Quantitation of the acid and lactone forms of atorvastatin and its biotransformation products in human serum by high-performance liquid chromatography with electrospray tandem mass spectrometry
    • DOI 10.1002/(SICI)1097-0231(19990615)13:11<1003::AID-RCM597>3.0. CO;2-L
    • Jemal M, Ouyang Z, Chen B, Teitz D. Quantiation of the acid and lactone forms of atorvastatin and its biotransformation products in humans serum by high-performance liquid chromatography with electrospray tandem mass spectrometry. Rapid Comm Mass Spectr. 1999;13:1003-1015. (Pubitemid 29257202)
    • (1999) Rapid Communications in Mass Spectrometry , vol.13 , Issue.11 , pp. 1003-1015
    • Jemal, M.1    Ouyang, Z.2    Chen, B.-C.3    Teitz, D.4
  • 42
    • 65949114640 scopus 로고    scopus 로고
    • Applicability of nonlinear calibration regression for the determination of parent and metabolite(s) in bioequivalence assessments
    • Srinivas NR. Applicability of nonlinear calibration regression for the determination of parent and metabolite(s) in bioequivalence assessments. Biomed Chromatogr. 2008;22:1315-1317.
    • (2008) Biomed Chromatogr , vol.22 , pp. 1315-1317
    • Srinivas, N.R.1
  • 43
    • 58149148297 scopus 로고    scopus 로고
    • Characterization of a new norfloxacin metabolite monitored during a bioequivalence study by means of mass spectrometry and quantum computation
    • Medvedovici A, Sora DL, Ionesscu S, Hillberand M, David V. Characterization of a new norfloxacin metabolite monitored during a bioequivalence study by means of mass spectrometry and quantum computation. Biomed Chromatogr. 2008;22:1100-1107.
    • (2008) Biomed Chromatogr , vol.22 , pp. 1100-1107
    • Medvedovici, A.1    Sora, D.L.2    Ionesscu, S.3    Hillberand, M.4    David, V.5
  • 44
    • 53049087887 scopus 로고    scopus 로고
    • Pharmacokinetic and safety profile of rupatadine when coadministered with azithromycin at steadystate levels: A randomized, open-label, two-way, crossover, phase I study
    • Solans A, Izquierdo I, Donado E, Antonijoan R, Peña J, Nadal T, et al. Pharmacokinetic and safety profile of rupatadine when coadministered with azithromycin at steadystate levels: A randomized, open-label, two-way, crossover, phase I study. Clin Ther. 2008;30:1639-1650.
    • (2008) Clin Ther , vol.30 , pp. 1639-1650
    • Solans, A.1    Izquierdo, I.2    Donado, E.3    Antonijoan, R.4    Peña, J.5    Nadal, T.6
  • 45
    • 33750443580 scopus 로고    scopus 로고
    • Nasal delivery of antimigraine drugs: Clinical rationale and evidence base
    • DOI 10.1111/j.1526-4610.2006.00603.x
    • Rapoport A, Winner P. Nasal delivery of antimigraine drugs: clinical rationale and evidence base. Headache. 2006;46:S192-S201. (Pubitemid 44656904)
    • (2006) Headache , vol.46 , Issue.SUPPL. 4
    • Rapoport, A.1    Winner, P.2
  • 46
    • 34248654863 scopus 로고    scopus 로고
    • Uptake and biodistribution of rizatriptan to blood and brain following different routes of administration in rats
    • DOI 10.1016/j.ijpharm.2006.12.039, PII S0378517307000087
    • Wang C, Quan LH, Guo Y, Liu CY, Liao YH. Uptake and biodistribution of rizatriptan to blood and brain following different routes of administration in rats. Int J Pharm. 2007;337:155-160. (Pubitemid 46766618)
    • (2007) International Journal of Pharmaceutics , vol.337 , Issue.1-2 , pp. 155-160
    • Wang, C.1    Quan, L.-H.2    Guo, Y.3    Liu, C.-Y.4    Liao, Y.-H.5
  • 47
    • 16244362023 scopus 로고    scopus 로고
    • Bioequivalence and rapid absorption of zolmitriptan nasal spray compared with oral tablets in healthy Japanese subjects
    • DOI 10.2165/00044011-200525030-00006
    • Uemura N, Onishi T, Mitaniyama A, Kaneko T, Ninomiya K, Nakamura K. et al. Bioequivalence and rapid absorption of zolmitriptan nasal spray compared with oral tablets in healthy Japanese subjects. Clin Drug Investig. 2005;25:199-208. (Pubitemid 40460646)
    • (2005) Clinical Drug Investigation , vol.25 , Issue.3 , pp. 199-208
    • Uemura, N.1    Onishi, T.2    Mitaniyama, A.3    Kaneko, T.4    Ninomiya, K.5    Nakamura, K.6    Tateno, M.7


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