메뉴 건너뛰기




Volumn 29, Issue 11, 2012, Pages 3188-3198

Elucidating the role of dose in the biopharmaceutics classification of drugs: The concepts of critical dose, effective in vivo solubility, and dose-dependent BCS

Author keywords

BCS; critical dose; DDBCS; dose; effective in vivo solubility

Indexed keywords

DICLOFENAC; KETOPROFEN; METOPROLOL;

EID: 84867851507     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-012-0815-4     Document Type: Article
Times cited : (23)

References (69)
  • 1
    • 0022070123 scopus 로고
    • Absorption potential: Estimating the fraction absorbed for orally administered compounds
    • 4020642 10.1002/jps.2600740523 1:CAS:528:DyaL2MXktFKgur0%3D
    • Dressman JB, Amidon GL, Fleisher D. Absorption potential: estimating the fraction absorbed for orally administered compounds. J Pharm Sci. 1985;74(5):588-9.
    • (1985) J Pharm Sci , vol.74 , Issue.5 , pp. 588-589
    • Dressman, J.B.1    Amidon, G.L.2    Fleisher, D.3
  • 2
    • 0024578889 scopus 로고
    • Toward a quantitative approach for the prediction of the fraction of dose absorbed using the absorption potential concept
    • 2923960 10.1002/bdd.2510100106 1:CAS:528:DyaL1MXosl2ktQ%3D%3D
    • Macheras PE, Symillides MY. Toward a quantitative approach for the prediction of the fraction of dose absorbed using the absorption potential concept. Biopharm Drug Dispos. 1989;10(1):43-53.
    • (1989) Biopharm Drug Dispos , vol.10 , Issue.1 , pp. 43-53
    • MacHeras, P.E.1    Symillides, M.Y.2
  • 3
    • 0030444550 scopus 로고    scopus 로고
    • Guidance in the setting of drug particle size specifications to minimize variability in absorption
    • 8987073 10.1023/A:1016068705255 1:CAS:528:DyaK2sXkvFGrtw%3D%3D
    • Johnson KC, Swindell AC. Guidance in the setting of drug particle size specifications to minimize variability in absorption. Pharm Res. 1996;13:1795-8.
    • (1996) Pharm Res , vol.13 , pp. 1795-1798
    • Johnson, K.C.1    Swindell, A.C.2
  • 4
    • 0033427120 scopus 로고    scopus 로고
    • An integrated model for determining causes of poor oral drug absorption
    • 10644078 10.1023/A:1018911728161 1:CAS:528:DC%2BD3cXkt1entg%3D%3D
    • Yu LX. An integrated model for determining causes of poor oral drug absorption. Pharm Res. 1999;16:1883-7.
    • (1999) Pharm Res , vol.16 , pp. 1883-1887
    • Yu, L.X.1
  • 5
    • 84867103706 scopus 로고    scopus 로고
    • Integrating drug permeability with dissolution profile to develop IVIVC
    • doi: 10.1002/bdd.1792
    • Takano R, Kataoka M, Yamashita S. Integrating drug permeability with dissolution profile to develop IVIVC. Biopharm Drug Disp. 2012;doi: 10.1002/bdd.1792.
    • (2012) Biopharm Drug Disp.
    • Takano, R.1    Kataoka, M.2    Yamashita, S.3
  • 6
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutics drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • 7617530 10.1023/A:1016212804288 1:CAS:528:DyaK2MXksVGqur8%3D
    • Amidon G, Lennarnas H, Shah V, Crison J. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-29.
    • (1995) Pharm Res , vol.12 , Issue.3 , pp. 413-429
    • Amidon, G.1    Lennarnas, H.2    Shah, V.3    Crison, J.4
  • 8
    • 1242337282 scopus 로고    scopus 로고
    • The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs
    • Yazdanian M, Briggs K, Jankovsky C, Hawi A. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharm Res. 2004;21(2):293-9.
    • (2004) Pharm Res. , vol.21 , Issue.2 , pp. 293-299
    • Yazdanian, M.1    Briggs, K.2    Jankovsky, C.3    Hawi, A.4
  • 9
    • 15244341878 scopus 로고    scopus 로고
    • Identification of biowaivers among Class II drugs: Theoretical justification and practical examples
    • 15497681 10.1023/B:PHAM.0000041450.25106.c8 1:CAS:528: DC%2BD2cXnsFyjsLs%3D
    • Rinaki E, Dokoumetzidis A, Valsami G, Macheras P. Identification of biowaivers among Class II drugs: theoretical justification and practical examples. Pharm Res. 2004;21(9):1567-72.
    • (2004) Pharm Res , vol.21 , Issue.9 , pp. 1567-1572
    • Rinaki, E.1    Dokoumetzidis, A.2    Valsami, G.3    MacHeras, P.4
  • 10
    • 0348107338 scopus 로고    scopus 로고
    • Quantitative biopharmaceutics classification system: The central role of dose/solubility ratio
    • 14725354 10.1023/B:PHAM.0000008037.57884.11 1:CAS:528: DC%2BD3sXpvVShsLg%3D
    • Rinaki E, Valsami G, Macheras P. Quantitative biopharmaceutics classification system: the central role of dose/solubility ratio. Pharm Res. 2003;20(12):1917-25.
    • (2003) Pharm Res , vol.20 , Issue.12 , pp. 1917-1925
    • Rinaki, E.1    Valsami, G.2    MacHeras, P.3
  • 11
    • 17644380257 scopus 로고    scopus 로고
    • Predicting drug disposition via application of BCS: Transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system
    • 15771225 10.1007/s11095-004-9004-4 1:CAS:528:DC%2BD2MXhtlCks70%3D
    • Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11-23.
    • (2005) Pharm Res , vol.22 , Issue.1 , pp. 11-23
    • Wu, C.Y.1    Benet, L.Z.2
  • 13
    • 83555174958 scopus 로고    scopus 로고
    • BDDCS applied to over 900 drugs
    • 21818695 10.1208/s12248-011-9290-9 1:CAS:528:DC%2BC3MXhsFamsbfE
    • Benet LZ, Broccatelli F, Oprea TI. BDDCS applied to over 900 drugs. AAPS J. 2011;13(4):519-47.
    • (2011) AAPS J , vol.13 , Issue.4 , pp. 519-547
    • Benet, L.Z.1    Broccatelli, F.2    Oprea, T.I.3
  • 15
    • 0027473738 scopus 로고
    • Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans: A mathematical model
    • 8456075 10.1023/A:1018947113238 1:CAS:528:DyaK3sXhs1SmsLw%3D
    • Oh DM, Curl RL, Amidon GL. Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans: a mathematical model. Pharm Res. 1993;10(2):264-70.
    • (1993) Pharm Res , vol.10 , Issue.2 , pp. 264-270
    • Oh, D.M.1    Curl, R.L.2    Amidon, G.L.3
  • 16
    • 0029848457 scopus 로고    scopus 로고
    • Compartmental transit and dispersion model analysis of small intestinal transit flow in humans
    • Yu LX, Crison JR, Amidon GL. Compartmental transit and dispersion model analysis of small intestinal transit flow in humans. Int J Pharm. 1996;140(1):111-8.
    • (1996) Int J Pharm. , vol.140 , Issue.1 , pp. 111-118
    • Yu, L.X.1    Crison, J.R.2    Amidon, G.L.3
  • 17
    • 77149165406 scopus 로고    scopus 로고
    • Predicting drug disposition via application of a Biopharmaceutics Drug Disposition Classification System
    • 20002064 10.1111/j.1742-7843.2009.00498.x 1:CAS:528:DC%2BC3cXivVShtLY%3D
    • Benet LZ. Predicting drug disposition via application of a Biopharmaceutics Drug Disposition Classification System. Basic Clin Pharmacol Toxicol. 2010;106(3):162-7.
    • (2010) Basic Clin Pharmacol Toxicol , vol.106 , Issue.3 , pp. 162-167
    • Benet, L.Z.1
  • 18
    • 77955921793 scopus 로고    scopus 로고
    • The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted
    • 20668447 10.1038/clpt.2010.149 1:STN:280:DC%2BC3cjmtFWqsQ%3D%3D
    • Benet LZ, Larregieu CA. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted. Clin Pharmacol Ther. 2010;88(3):405-7.
    • (2010) Clin Pharmacol Ther , vol.88 , Issue.3 , pp. 405-407
    • Benet, L.Z.1    Larregieu, C.A.2
  • 19
    • 0030796952 scopus 로고    scopus 로고
    • Gastrointestinal drug absorption: Is it time to consider heterogeneity as well as homogeneity?
    • 9244138 10.1023/A:1012183313218 1:CAS:528:DyaK2sXkvVCjs7c%3D
    • Macheras P, Argyrakis P. Gastrointestinal drug absorption: is it time to consider heterogeneity as well as homogeneity? Pharm Res. 1997;14(7):842-7.
    • (1997) Pharm Res , vol.14 , Issue.7 , pp. 842-847
    • MacHeras, P.1    Argyrakis, P.2
  • 20
    • 52249112060 scopus 로고    scopus 로고
    • IVIVC of controlled release formulations: Physiological-dynamical reasons for their failure
    • 18538435 10.1016/j.jconrel.2008.04.005 1:CAS:528:DC%2BD1cXnsFalurw%3D
    • Dokoumetzidis A, Macheras P. IVIVC of controlled release formulations: physiological-dynamical reasons for their failure. J Control Release. 2008;129(2):76-8.
    • (2008) J Control Release , vol.129 , Issue.2 , pp. 76-78
    • Dokoumetzidis, A.1    MacHeras, P.2
  • 21
    • 84878715231 scopus 로고    scopus 로고
    • GastroPlus™ Simulation Plus inc.
    • GastroPlus™ Simulation Plus inc. Available from: http://www.simulations-plus.com/Products.aspx?grpID=3&cID=16&pID=11.
  • 23
    • 84878703582 scopus 로고    scopus 로고
    • PK-Sim®
    • PK-Sim® Available from: http://www.systems-biology.com/products/pk- sim.html.
  • 24
    • 84860784465 scopus 로고    scopus 로고
    • Identification of suitable formulations for high dose oral studies in rats using in vitro solubility measurements, the maximum absorbable dose model, and historical data sets
    • Wuelfing WP, Kwong E, Higgins J. Identification of suitable formulations for high dose oral studies in rats using in vitro solubility measurements, the maximum absorbable dose model, and historical data sets. Mol Pharm. 2012;7;9(5):1163-74.
    • (2012) Mol Pharm. , vol.7-9 , Issue.5 , pp. 1163-1174
    • Wuelfing, W.P.1    Kwong, E.2    Higgins, J.3
  • 25
    • 84859104300 scopus 로고    scopus 로고
    • Developability assessment of clinical drug products with maximum absorbable doses
    • 22349050 10.1016/j.ijpharm.2012.02.003 1:CAS:528:DC%2BC38XjtF2hsbk%3D
    • Ding X, Rose JP, Van Gelder J. Developability assessment of clinical drug products with maximum absorbable doses. Int J Pharm. 2012;427(2):260-9.
    • (2012) Int J Pharm , vol.427 , Issue.2 , pp. 260-269
    • Ding, X.1    Rose, J.P.2    Van Gelder, J.3
  • 26
    • 82255179484 scopus 로고    scopus 로고
    • Understanding the performance of melt-extruded poly(ethylene oxide)-bicalutamide solid dispersions: Characterisation of microstructural properties using thermal, spectroscopic and drug release methods
    • 21905037 10.1002/jps.22748 1:CAS:528:DC%2BC3MXhtFersLfI
    • Abu-Diak OA, Jones DS, Andrews GP. Understanding the performance of melt-extruded poly(ethylene oxide)-bicalutamide solid dispersions: characterisation of microstructural properties using thermal, spectroscopic and drug release methods. J Pharm Sci. 2012;101(1):200-13.
    • (2012) J Pharm Sci , vol.101 , Issue.1 , pp. 200-213
    • Abu-Diak, O.A.1    Jones, D.S.2    Andrews, G.P.3
  • 27
    • 0030744475 scopus 로고    scopus 로고
    • The effect of food on the pharmacokinetics of the bicalutamide (Casodex) enantiomers
    • 10.1002/(SICI)1099-081X(199708)18:6<499: AID-BDD37>3.0.CO;2-J 1:CAS:528:DyaK2sXlsFeitrg%3D
    • Cockshott ID, Oliver SD, Young JJ, et al. The effect of food on the pharmacokinetics of the bicalutamide (Casodex) enantiomers. Biopharm Drug Disp. 1997;18(6):499-507.
    • (1997) Biopharm Drug Disp , vol.18 , Issue.6 , pp. 499-507
    • Cockshott, I.D.1    Oliver, S.D.2    Young, J.J.3
  • 28
    • 7444242095 scopus 로고    scopus 로고
    • Bicalutamide. Clinical pharmacokinetics and metabolism
    • 10.2165/00003088-200443130-00003 1:CAS:528:DC%2BD2cXhtVGjsr7J
    • Cockshott ID. Bicalutamide. Clinical pharmacokinetics and metabolism. Clin Pharmacok. 2004;43(13):855-78.
    • (2004) Clin Pharmacok , vol.43 , Issue.13 , pp. 855-878
    • Cockshott, I.D.1
  • 29
    • 0018574044 scopus 로고
    • The pharmacokinetics of diclofenac sodium following intravenous and oral administration
    • 527637 10.1007/BF00568201 1:CAS:528:DyaL3cXhsVSgu70%3D
    • Willis JV, Kendall MJ, Flinn RM, Thornhill DP, Welling PG. The pharmacokinetics of diclofenac sodium following intravenous and oral administration. Eur J Clin Pharmacol. 1979;16(6):405-10.
    • (1979) Eur J Clin Pharmacol , vol.16 , Issue.6 , pp. 405-410
    • Willis, J.V.1    Kendall, M.J.2    Flinn, R.M.3    Thornhill, D.P.4    Welling, P.G.5
  • 30
    • 11844287544 scopus 로고    scopus 로고
    • No effect of short term ranitidine intake on diclofenac pharmacokinetics
    • 15624028
    • Leucuţa A, Vlase L, Farcau D, Nanulescu M. No effect of short term ranitidine intake on diclofenac pharmacokinetics. Rom J Gastroenterol. 2004;13(4):306-8.
    • (2004) Rom J Gastroenterol , vol.13 , Issue.4 , pp. 306-308
    • Leucuţa, A.1    Vlase, L.2    Farcau, D.3    Nanulescu, M.4
  • 31
    • 70350731413 scopus 로고    scopus 로고
    • Bioequivalence study of low-dose diclofenac potassium tablet formulations
    • 19825328 1:CAS:528:DC%2BD1MXhsVWrurrE
    • Hinz B, Hug AM, Fotopoulos G, Gold MS. Bioequivalence study of low-dose diclofenac potassium tablet formulations. Int J Clin Pharmacol Ther. 2009;47(10):643-8.
    • (2009) Int J Clin Pharmacol Ther , vol.47 , Issue.10 , pp. 643-648
    • Hinz, B.1    Hug, A.M.2    Fotopoulos, G.3    Gold, M.S.4
  • 33
    • 0031755956 scopus 로고    scopus 로고
    • Comparative pharmacokinetic study of a single dose of two prolonged-release formulations of diclofenac in healthy subjects
    • 10.1016/S0011-393X(98)85104-7
    • Biasia G, Canova N, Palazzini E, Marcolongo R. Comparative pharmacokinetic study of a single dose of two prolonged-release formulations of diclofenac in healthy subjects. Current Ther Res. 1998;59(1):785-92.
    • (1998) Current Ther Res , vol.59 , Issue.1 , pp. 785-792
    • Biasia, G.1    Canova, N.2    Palazzini, E.3    Marcolongo, R.4
  • 34
    • 33847787350 scopus 로고    scopus 로고
    • Diclofenac solubility: Independent determination of the intrinsic solubility of three crystal forms
    • 10.1021/jm0612970
    • Llinàs A, Burley JC, Box KJ, Glen RC, Goodman JM. Diclofenac solubility: independent determination of the intrinsic solubility of three crystal forms. Med Chem. 2007;50(5):979-83.
    • (2007) Med Chem , vol.50 , Issue.5 , pp. 979-983
    • Llinàs, A.1    Burley, J.C.2    Box, K.J.3    Glen, R.C.4    Goodman, J.M.5
  • 35
    • 79953022197 scopus 로고    scopus 로고
    • Evaluation of in vitro equivalence for drugs containing BCS class II compound ketoprofen
    • 1:CAS:528:DC%2BC3MXkvVeju7Y%3D
    • Shohin I, Kulinich J, Ramenskaya GV, Vasilenko GF. Evaluation of in vitro equivalence for drugs containing BCS class II compound ketoprofen. Dissol Tech. 2011;18:26-9.
    • (2011) Dissol Tech , vol.18 , pp. 26-29
    • Shohin, I.1    Kulinich, J.2    Ramenskaya, G.V.3    Vasilenko, G.F.4
  • 36
    • 0029067669 scopus 로고
    • Pharmacokinetics of ketoprofen enantiomers after different doses of the racemate
    • 8527271 10.1111/j.1365-2125.1995.tb04537.x 1:CAS:528:DyaK2MXnsVehurw%3D
    • Geisslinger G, Menzel S, Wissel K, Brune K. Pharmacokinetics of ketoprofen enantiomers after different doses of the racemate. Br J Clin Pharmacol. 1995;40:73-5.
    • (1995) Br J Clin Pharmacol , vol.40 , pp. 73-75
    • Geisslinger, G.1    Menzel, S.2    Wissel, K.3    Brune, K.4
  • 37
    • 0025126914 scopus 로고
    • Clinical pharmacokinetics of ketoprofen and its enantiomers
    • 2203580 10.2165/00003088-199019030-00004 1:STN:280:DyaK3czmslertA%3D%3D
    • Jamali F, Brocks DR. Clinical pharmacokinetics of ketoprofen and its enantiomers. Clin Pharmacokinet. 1990;19(3):197-217.
    • (1990) Clin Pharmacokinet , vol.19 , Issue.3 , pp. 197-217
    • Jamali, F.1    Brocks, D.R.2
  • 38
    • 47949129181 scopus 로고    scopus 로고
    • Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCS-MD): Theoretical basis and practical examples
    • 18614303 10.1016/j.ijpharm.2008.05.021 1:CAS:528:DC%2BD1cXpt1alsL4%3D
    • Papadopoulou V, Valsami G, Dokoumetzidis A, Macheras P. Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCS-MD): theoretical basis and practical examples. Int J Pharm. 2008;361:70-7.
    • (2008) Int J Pharm , vol.361 , pp. 70-77
    • Papadopoulou, V.1    Valsami, G.2    Dokoumetzidis, A.3    MacHeras, P.4
  • 40
    • 0025108794 scopus 로고
    • Drug binding and solubility in milk
    • 1694991 10.1023/A:1015881103340 1:CAS:528:DyaK3cXkvVCksLw%3D
    • Macheras P, Koupparis M, Antimisiaris S. Drug binding and solubility in milk. Pharm Res. 1990;7(5):537-41.
    • (1990) Pharm Res , vol.7 , Issue.5 , pp. 537-541
    • MacHeras, P.1    Koupparis, M.2    Antimisiaris, S.3
  • 41
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of class i and II drugs
    • 9619777 10.1023/A:1011910801212 1:CAS:528:DyaK1cXjtlWhsL8%3D
    • Galia E, Nicolaides E, Hoerter D, Loebenberg R, Reppas C, Dressman J. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm Res. 1998;15(5):698-705.
    • (1998) Pharm Res , vol.15 , Issue.5 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Hoerter, D.3    Loebenberg, R.4    Reppas, C.5    Dressman, J.6
  • 42
    • 77951499450 scopus 로고    scopus 로고
    • Novel milk-based oral formulations: Proof of concept
    • 20117197 10.1016/j.ijpharm.2010.01.038 1:CAS:528:DC%2BC3cXksFShtrY%3D
    • Charkoftaki G, Kytariolos J, Macheras P. Novel milk-based oral formulations: proof of concept. Int J Pharm. 2010;390(2):150-9.
    • (2010) Int J Pharm , vol.390 , Issue.2 , pp. 150-159
    • Charkoftaki, G.1    Kytariolos, J.2    MacHeras, P.3
  • 43
    • 32244434196 scopus 로고    scopus 로고
    • Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies
    • 16715357 10.1007/s11095-006-0207-8 1:CAS:528:DC%2BD28XmtFCnsLs%3D
    • Kalantzi L, Persson E, Polentarutti B, Abrahamsson B, Goumas K, Dressman J, Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies. Pharm Res. 2006;23(1):1373-81.
    • (2006) Pharm Res , vol.23 , Issue.1 , pp. 1373-1381
    • Kalantzi, L.1    Persson, E.2    Polentarutti, B.3    Abrahamsson, B.4    Goumas, K.5    Dressman, J.6    Reppas, C.7
  • 44
    • 34247612824 scopus 로고    scopus 로고
    • In vitro behavior of a phosphate ester prodrug of amprenavir in human intestinal fluids and in the Caco-2 system: Illustration of intraluminal supersaturation
    • 17207947 10.1016/j.ijpharm.2006.12.011 1:CAS:528:DC%2BD2sXkvFWqu7c%3D
    • Brouwers J, Tack J, Augustijns P. In vitro behavior of a phosphate ester prodrug of amprenavir in human intestinal fluids and in the Caco-2 system: Illustration of intraluminal supersaturation. Int J Pharm. 2007;336(2):302-9.
    • (2007) Int J Pharm , vol.336 , Issue.2 , pp. 302-309
    • Brouwers, J.1    Tack, J.2    Augustijns, P.3
  • 45
    • 67349204296 scopus 로고    scopus 로고
    • Postprandial changes in solubilizing capacity of human intestinal fluids for BCS Class II drugs
    • 19267186 10.1007/s11095-009-9857-7 1:CAS:528:DC%2BD1MXivVajtr4%3D
    • Clarysse S, Psachoulias D, Brouwers J, Tack J, Annaert P, Duchateau G, Reppas C, Augustijns P. Postprandial changes in solubilizing capacity of human intestinal fluids for BCS Class II drugs. Pharm Res. 2009;26(6):1456-66.
    • (2009) Pharm Res , vol.26 , Issue.6 , pp. 1456-1466
    • Clarysse, S.1    Psachoulias, D.2    Brouwers, J.3    Tack, J.4    Annaert, P.5    Duchateau, G.6    Reppas, C.7    Augustijns, P.8
  • 48
    • 67349237855 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms: Diclofenac sodium and diclofenac potassium
    • 18752289 10.1002/jps.21525 1:CAS:528:DC%2BD1MXktlSisLg%3D
    • Chuasuwan B, Binjedoh V, Polli JE, Zhang H, Amidon GL, Junginger HE, Shah MKK, et al. Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium. J Pharm Sci. 2009;98(4):1206-19.
    • (2009) J Pharm Sci , vol.98 , Issue.4 , pp. 1206-1219
    • Chuasuwan, B.1    Binjedoh, V.2    Polli, J.E.3    Zhang, H.4    Amidon, G.L.5    Junginger, H.E.6    Shah, M.K.K.7
  • 49
    • 67650218291 scopus 로고    scopus 로고
    • Barends DMBiowaiver monographs for immediate release solid oral dosage forms: Rifampicin
    • 19160441 10.1002/jps.21624 1:CAS:528:DC%2BD1MXmslCgt7c%3D
    • Becker C, Dressman JB, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S. Barends DM. Biowaiver monographs for immediate release solid oral dosage forms: rifampicin. J Pharm Sci. 2009;98(7):2252-67.
    • (2009) J Pharm Sci , vol.98 , Issue.7 , pp. 2252-2267
    • Becker, C.1    Dressman, J.B.2    Junginger, H.E.3    Kopp, S.4    Midha, K.K.5    Shah, V.P.6    Stavchansky, S.7
  • 50
    • 79151472560 scopus 로고    scopus 로고
    • Intravenous ibuprofen: The first injectable product for the treatment of pain and fever
    • 21197311 10.2147/JPR.S6993 1:CAS:528:DC%2BC3cXntFWjsrg%3D
    • Bookstaver BP, Miller AD, Rudisill CN, Norris B. Intravenous ibuprofen: the first injectable product for the treatment of pain and fever. J Pain Res. 2010;3:67-79.
    • (2010) J Pain Res , vol.3 , pp. 67-79
    • Bookstaver, B.P.1    Miller, A.D.2    Rudisill, C.N.3    Norris, B.4
  • 51
    • 0019955132 scopus 로고
    • Relative bioavailability of commercially available ibuprofen oral dosage forms in humans
    • 7131270 10.1002/jps.2600710920 1:CAS:528:DyaL38Xls1yku7g%3D
    • Gillespie WR, DiSanto AR, Monovich RE, Albert KS. Relative bioavailability of commercially available ibuprofen oral dosage forms in humans. J Pharm Sci. 1982;71(9):1034-8.
    • (1982) J Pharm Sci , vol.71 , Issue.9 , pp. 1034-1038
    • Gillespie, W.R.1    Disanto, A.R.2    Monovich, R.E.3    Albert, K.S.4
  • 52
    • 0025171473 scopus 로고
    • The relationship between the pharmacokinetics of ibuprofen enantiomers and the dose of racemic ibuprofen in humans
    • 2207301 10.1002/bdd.2510110605 1:CAS:528:DyaK3cXlsVCrtrk%3D
    • Evans AM, Nation RL, Sansom LN, Bochner F, Somogyi AA. The relationship between the pharmacokinetics of ibuprofen enantiomers and the dose of racemic ibuprofen in humans. Biopharm Drug Dispos. 1990;11(6):507-18.
    • (1990) Biopharm Drug Dispos , vol.11 , Issue.6 , pp. 507-518
    • Evans, A.M.1    Nation, R.L.2    Sansom, L.N.3    Bochner, F.4    Somogyi, A.A.5
  • 53
    • 27944492442 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms: Ibuprofen
    • 33
    • Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP et al. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci. 2005;94(10):2121-2131.33.
    • (2005) J Pharm Sci. , vol.94 , Issue.10 , pp. 2121-2131
    • Potthast, H.1    Dressman, J.B.2    Junginger, H.E.3    Midha, K.K.4    Oeser, H.5    Shah, V.P.6
  • 54
    • 0034069608 scopus 로고    scopus 로고
    • Solubility and dissolution properties of generic rifampicin raw materials
    • 10769781 10.1081/DDC-100101246 1:CAS:528:DC%2BD3cXisFWitbY%3D
    • Henwood SQ, de Villiers MM, Liebenberg W, Lötter AP. Solubility and dissolution properties of generic rifampicin raw materials. Drug Dev Ind Pharm. 2000;26(4):403-8.
    • (2000) Drug Dev Ind Pharm , vol.26 , Issue.4 , pp. 403-408
    • Henwood, S.Q.1    De Villiers, M.M.2    Liebenberg, W.3    Lötter, A.P.4
  • 55
    • 0032867063 scopus 로고    scopus 로고
    • Comparative bioavailability of three different preparations of rifampicin
    • 10438182 10.1046/j.1365-2710.1999.00223.x
    • Pähkla R, Lambert J, Ansko P, Winstanley P, Davies PD, Kiivet RA. Comparative bioavailability of three different preparations of rifampicin. J Clin Pharm Ther. 1999;24(3):219-25.
    • (1999) J Clin Pharm Ther , vol.24 , Issue.3 , pp. 219-225
    • Pähkla, R.1    Lambert, J.2    Ansko, P.3    Winstanley, P.4    Davies, P.D.5    Kiivet, R.A.6
  • 56
    • 78650598044 scopus 로고    scopus 로고
    • A bioequivalence comparison of two formulations of rifampicin (300- vs 150-mg capsules): An open-label, randomized, two-treatment, two-way crossover study in healthy volunteers
    • 21194606 10.1016/j.clinthera.2010.09.006 1:CAS:528:DC%2BC3MXisFCmug%3D%3D
    • Chik Z, Basu RC, Pendek R, Lee TC, Mohamed Z. A bioequivalence comparison of two formulations of rifampicin (300- vs 150-mg capsules): An open-label, randomized, two-treatment, two-way crossover study in healthy volunteers. Clin Ther. 2010;32(10):1822-31.
    • (2010) Clin Ther , vol.32 , Issue.10 , pp. 1822-1831
    • Chik, Z.1    Basu, R.C.2    Pendek, R.3    Lee, T.C.4    Mohamed, Z.5
  • 57
    • 77953607618 scopus 로고    scopus 로고
    • Pharmacokinetic studies of rifampicin in healthy volunteers and tuberculosis patients
    • 1:CAS:528:DC%2BC3cXotFKqsbY%3D
    • Rafiq S, Iqbal T, Jamil A, Khan FH. Pharmacokinetic studies of rifampicin in healthy volunteers and tuberculosis patients. Int J Agric Biol. 2010;12:391-5.
    • (2010) Int J Agric Biol , vol.12 , pp. 391-395
    • Rafiq, S.1    Iqball, T.2    Jamil, A.3    Khan, F.H.4
  • 58
    • 34447289616 scopus 로고    scopus 로고
    • Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients
    • 17452486 10.1128/AAC.01550-06 1:CAS:528:DC%2BD2sXnsVajsrk%3D
    • Ruslami R, Nijland MJH, Alisjahbanaa B, Parwati I, van Crevel R, Rob AE. Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients. Antimicrob Agents Chemother. 2007;51(7):2546-51.
    • (2007) Antimicrob Agents Chemother , vol.51 , Issue.7 , pp. 2546-2551
    • Ruslami, R.1    Nijland, M.J.H.2    Alisjahbanaa, B.3    Parwati, I.4    Van Crevel, R.5    Rob, A.E.6
  • 59
    • 79952472980 scopus 로고    scopus 로고
    • Quantitative determination of atorvastatin and ortho-hydroxy atorvastatin in human plasma by liquid chromatography tandem mass spectrometry and pharmacokinetic evaluation
    • 21069099 10.1358/mf.2010.32.7.1487086 1:CAS:528:DC%2BC3MXht1Wms7fM
    • He BX, Shi L, Qiu J, Zeng XH, Tao L, Li R, Hong CJ, Gu XL, Dong FY, Yang L, Zhao SJ. Quantitative determination of atorvastatin and ortho-hydroxy atorvastatin in human plasma by liquid chromatography tandem mass spectrometry and pharmacokinetic evaluation. Methods Find Exp Clin Pharmacol. 2010;32(7):481-7.
    • (2010) Methods Find Exp Clin Pharmacol , vol.32 , Issue.7 , pp. 481-487
    • He, B.X.1    Shi, L.2    Qiu, J.3    Zeng, X.H.4    Tao, L.5    Li, R.6    Hong, C.J.7    Gu, X.L.8    Dong, F.Y.9    Yang, L.10    Zhao, S.J.11
  • 60
    • 77955251731 scopus 로고    scopus 로고
    • Pharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males
    • 20678686 10.1016/j.clinthera.2010.07.004 1:CAS:528:DC%2BC3cXht1yjtrbO
    • Liu YM, Pu HH, Liu GY, Jia JY, Weng LP, Xu RJ, Li GX, Wang W, Zhang MQ, Lu C, Yu C. Pharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males. Clin Ther. 2010;32(7):1396-407.
    • (2010) Clin Ther , vol.32 , Issue.7 , pp. 1396-1407
    • Liu, Y.M.1    Pu, H.H.2    Liu, G.Y.3    Jia, J.Y.4    Weng, L.P.5    Xu, R.J.6    Li, G.X.7    Wang, W.8    Zhang, M.Q.9    Lu, C.10    Yu, C.11
  • 61
    • 49649084692 scopus 로고    scopus 로고
    • A study of the pharmacokinetic interaction of istradefylline, a novel therapeutic for Parkinson's disease, and atorvastatin
    • 18552277 10.1177/0091270008320924 1:CAS:528:DC%2BD1cXhtFaqs7bN
    • Rao N, Dvorchik B, Sussman N, Wang H, Yamamoto K, Mori A, Uchimura T, Chaikin P. A study of the pharmacokinetic interaction of istradefylline, a novel therapeutic for Parkinson's disease, and atorvastatin. J Clin Pharmacol. 2008;48(9):1092-8.
    • (2008) J Clin Pharmacol , vol.48 , Issue.9 , pp. 1092-1098
    • Rao, N.1    Dvorchik, B.2    Sussman, N.3    Wang, H.4    Yamamoto, K.5    Mori, A.6    Uchimura, T.7    Chaikin, P.8
  • 63
    • 77953466987 scopus 로고    scopus 로고
    • Preparation and solid state characterization of atorvastatin nanosuspensions for enhanced solubility and dissolution
    • 1:CAS:528:DC%2BD1MXhsVaktb%2FN
    • Arunkumar N, Venkateskumar K, Deecaraman M, Rani C, Mohanraj KP. Preparation and solid state characterization of atorvastatin nanosuspensions for enhanced solubility and dissolution. Int J PharmTech Research. 2009;1(4):1725-30.
    • (2009) Int J PharmTech Research , vol.1 , Issue.4 , pp. 1725-1730
    • Arunkumar, N.1    Venkateskumar, K.2    Deecaraman, M.3    Rani, C.4    Mohanraj, K.P.5
  • 64
    • 10944259270 scopus 로고    scopus 로고
    • Biowaivers for oral immediate-release products. Implications of linear pharmacokinetics
    • 10.2165/00003088-200443150-00004
    • Faasen F, Vromans H. Biowaivers for oral immediate-release products. Implications of linear pharmacokinetics. Clin Pharmacokinet. 2004;43(15):1117-26.
    • (2004) Clin Pharmacokinet , vol.43 , Issue.15 , pp. 1117-1126
    • Faasen, F.1    Vromans, H.2
  • 66
    • 0018670197 scopus 로고
    • Linear pharmacokinetics of orally administered fenoprofen calcium
    • 501526 10.1002/jps.2600680907 1:CAS:528:DyaE1MXlvFyrt70%3D
    • Nash JF, Bechtol LD, Bunde CA, Bopp RJ, Farid KZ, Spradlin CT. Linear pharmacokinetics of orally administered fenoprofen calcium. J Pharm Sci. 1979;68(9):1087-90.
    • (1979) J Pharm Sci , vol.68 , Issue.9 , pp. 1087-1090
    • Nash, J.F.1    Bechtol, L.D.2    Bunde, C.A.3    Bopp, R.J.4    Farid, K.Z.5    Spradlin, C.T.6
  • 67
    • 0019483401 scopus 로고
    • Pharmacokinetics of prednisolone in normal and asthmatic subjects in relation to dose
    • 7262175 10.1007/BF00607151 1:CAS:528:DyaL3MXlsVCgsrg%3D
    • McAllister WA, Winfield CR, Collins JV. Pharmacokinetics of prednisolone in normal and asthmatic subjects in relation to dose. Eur J Clin Pharmacol. 1981;20(2):141-5.
    • (1981) Eur J Clin Pharmacol , vol.20 , Issue.2 , pp. 141-145
    • McAllister, W.A.1    Winfield, C.R.2    Collins, J.V.3
  • 68
    • 0030606872 scopus 로고    scopus 로고
    • Polymorphic transitions of cimetidine during manufacture of solid dosage forms
    • 10.1016/0378-5173(96)04587-5 1:CAS:528:DyaK28XlsFWrsro%3D
    • Bauer-Brandl A. Polymorphic transitions of cimetidine during manufacture of solid dosage forms. Int J Pharmaceutics. 1996;140(2):195-206.
    • (1996) Int J Pharmaceutics , vol.140 , Issue.2 , pp. 195-206
    • Bauer-Brandl, A.1
  • 69
    • 0018675750 scopus 로고
    • Bioavailability and pharmacokinetics of cimetidine
    • 520401 10.1007/BF00605632
    • Grahnén A, Bahr C, Lindström B, Rosén A. Bioavailability and pharmacokinetics of cimetidine. Eur J Clin Pharmacol. 1979;16(5):335-40.
    • (1979) Eur J Clin Pharmacol , vol.16 , Issue.5 , pp. 335-340
    • Grahnén, A.1    Bahr, C.2    Lindström, B.3    Rosén, A.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.