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Volumn 66, Issue , 2015, Pages 163-172

In vitro dissolution similarity factor (f2) and in vivo bioequivalence criteria, how and when do they match? Using a BCS class II drug as a simulation example

Author keywords

Bioequivalence; Dissolution; First order; Numerical convolution; Similarity factor; Simulation

Indexed keywords

FELODIPINE;

EID: 84910679899     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2014.10.002     Document Type: Article
Times cited : (64)

References (28)
  • 1
    • 80052568927 scopus 로고    scopus 로고
    • Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a Class II BCS drug using polymeric surfactants and crystallization inhibitors: Development of controlled-release tablets
    • E. Basalious, W. El-Sebaie, and O. El-Gazayerly Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a Class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets AAPS PharmSciTech 12 2011 799 810
    • (2011) AAPS PharmSciTech , vol.12 , pp. 799-810
    • Basalious, E.1    El-Sebaie, W.2    El-Gazayerly, O.3
  • 4
    • 0035806261 scopus 로고    scopus 로고
    • An alternative method to the evaluation of similarity factor in dissolution testing
    • P. Costa An alternative method to the evaluation of similarity factor in dissolution testing Int. J. Pharm. 220 2001 77 83
    • (2001) Int. J. Pharm. , vol.220 , pp. 77-83
    • Costa, P.1
  • 5
    • 0035073301 scopus 로고    scopus 로고
    • Modeling and comparison of dissolution profiles
    • P. Costa, and L.J. Sousa Modeling and comparison of dissolution profiles Eur. J. Pharm. Sci. 13 2001 123 133
    • (2001) Eur. J. Pharm. Sci. , vol.13 , pp. 123-133
    • Costa, P.1    Sousa, L.J.2
  • 6
    • 33747373878 scopus 로고    scopus 로고
    • A century of dissolution research: From Noyes and Whitney to the biopharmaceutics classification system
    • A. Dokoumetzidis, and P. Macheras A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system Int. J. Pharm. 321 2006 1 11
    • (2006) Int. J. Pharm. , vol.321 , pp. 1-11
    • Dokoumetzidis, A.1    Macheras, P.2
  • 7
    • 32544450657 scopus 로고    scopus 로고
    • Analysis of dissolution data using modified versions of Noyes-Whitney equation and the Weibull function
    • A. Dokoumetzidis, V. Papadopoulou, and P. Macheras Analysis of dissolution data using modified versions of Noyes-Whitney equation and the Weibull function Pharm. Res. 23 2006 256 261
    • (2006) Pharm. Res. , vol.23 , pp. 256-261
    • Dokoumetzidis, A.1    Papadopoulou, V.2    Macheras, P.3
  • 9
    • 79955593881 scopus 로고    scopus 로고
    • In vivo bioequivalence and in vitro similarity factor (f2) for dissolution profile comparisons of extended release formulations: How and when do they match?
    • J.Z. Duan, K. Riviere, and P. Marroum In vivo bioequivalence and in vitro similarity factor (f2) for dissolution profile comparisons of extended release formulations: how and when do they match? Pharm. Res. 28 2011 1144 1156
    • (2011) Pharm. Res. , vol.28 , pp. 1144-1156
    • Duan, J.Z.1    Riviere, K.2    Marroum, P.3
  • 10
    • 0025945594 scopus 로고
    • Felodipine clinical pharmacokinetics
    • P.H. Dunselman, and B. Edgar Felodipine clinical pharmacokinetics Clin. Pharmacokinet. 21 1991 418 430
    • (1991) Clin. Pharmacokinet. , vol.21 , pp. 418-430
    • Dunselman, P.H.1    Edgar, B.2
  • 11
    • 33745616771 scopus 로고    scopus 로고
    • In vitro - In vivo correlation: From theory to applications
    • J. Emami In vitro - in vivo correlation: from theory to applications J. Pharm. Pharm. Sci. 9 2006 169 189
    • (2006) J. Pharm. Pharm. Sci. , vol.9 , pp. 169-189
    • Emami, J.1
  • 17
    • 75549090422 scopus 로고    scopus 로고
    • In vitro dissolution testing with flow-through method: A technical note
    • Z. Gao In vitro dissolution testing with flow-through method: a technical note AAPS PharmSciTech 10 2009 1401 1405
    • (2009) AAPS PharmSciTech , vol.10 , pp. 1401-1405
    • Gao, Z.1
  • 19
    • 80052352943 scopus 로고    scopus 로고
    • Pharmacokinetics of felodipine extended-release tablets in healthy Taiwanese subjects: A retrospective review
    • C.L. Hsiao, Y.C. Wu, and K.Y. Hsu Pharmacokinetics of felodipine extended-release tablets in healthy Taiwanese subjects: a retrospective review Arzneimittelforschung 61 2011 444 451
    • (2011) Arzneimittelforschung , vol.61 , pp. 444-451
    • Hsiao, C.L.1    Wu, Y.C.2    Hsu, K.Y.3
  • 20
    • 0034434385 scopus 로고    scopus 로고
    • Application of in vitro-in vivo correlations (IVIVC) in setting formulation release specifications
    • N.B. Modi, A. Lam, E. Lindemulder, B. Wang, and S.K. Gupta Application of in vitro-in vivo correlations (IVIVC) in setting formulation release specifications Biopharm. Drug Dispos. 21 2000 321 326
    • (2000) Biopharm. Drug Dispos. , vol.21 , pp. 321-326
    • Modi, N.B.1    Lam, A.2    Lindemulder, E.3    Wang, B.4    Gupta, S.K.5
  • 21
    • 2342652446 scopus 로고    scopus 로고
    • Mathematical comparison of dissolution profiles
    • W.J. Moore, and H.H. Flanner Mathematical comparison of dissolution profiles Pharm. Technol. 20 1996 64 74
    • (1996) Pharm. Technol. , vol.20 , pp. 64-74
    • Moore, W.J.1    Flanner, H.H.2
  • 22
    • 78249285625 scopus 로고    scopus 로고
    • In Vitro-In Vivo Correlation (IVIVC) and determining drug concentrations in blood from dissolution testing - A simple and practical approach
    • S.A. Qureshi In Vitro-In Vivo Correlation (IVIVC) and determining drug concentrations in blood from dissolution testing - a simple and practical approach Open Drug Delivery J. 4 2010 38 47
    • (2010) Open Drug Delivery J. , vol.4 , pp. 38-47
    • Qureshi, S.A.1
  • 23
    • 78149499337 scopus 로고    scopus 로고
    • Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data
    • R.C. Rossi, C.L. Dias, L. Bajerski, A.M. Bergold, and P.E. Froehlich Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data J. Pharm. Biomed. Anal. 54 2011 439 444
    • (2011) J. Pharm. Biomed. Anal. , vol.54 , pp. 439-444
    • Rossi, R.C.1    Dias, C.L.2    Bajerski, L.3    Bergold, A.M.4    Froehlich, P.E.5
  • 26
    • 84910648630 scopus 로고    scopus 로고
    • Prediction of in vivo plasma concentration-time profile from in vitro release data of designed formulations of milnacipran using numerical convolution method
    • G. Singhvi, A. Shah, N. Yadav, and R.N. Saha Prediction of in vivo plasma concentration-time profile from in vitro release data of designed formulations of milnacipran using numerical convolution method Drug Dev. Ind. Pharm. 2013 1 4
    • (2013) Drug Dev. Ind. Pharm. , pp. 1-4
    • Singhvi, G.1    Shah, A.2    Yadav, N.3    Saha, R.N.4
  • 27
    • 0031864961 scopus 로고    scopus 로고
    • A review of methods used to compare dissolution profile data
    • A.D. Thomas O'Haraa A review of methods used to compare dissolution profile data Pharm. Sci. Technol. Today 1 1998 214 223
    • (1998) Pharm. Sci. Technol. Today , vol.1 , pp. 214-223
    • Thomas O'Haraa, A.D.1
  • 28
    • 77955960624 scopus 로고    scopus 로고
    • DDSolver: An add-in program for modeling and comparison of drug dissolution profiles
    • Y. Zhang, M. Huo, J. Zhou, A. Zou, W. Li, C. Yao, and S. Xie DDSolver: an add-in program for modeling and comparison of drug dissolution profiles AAPS J. 12 2010 263 271
    • (2010) AAPS J. , vol.12 , pp. 263-271
    • Zhang, Y.1    Huo, M.2    Zhou, J.3    Zou, A.4    Li, W.5    Yao, C.6    Xie, S.7


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