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Volumn 36, Issue 1, 2009, Pages 147-156

Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Part II. Non-linear kinetics

Author keywords

BCS; Bioequivalence; First pass metabolism; Single dose; Steady state

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; COMPUTER SIMULATION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG METABOLISM; DRUG PENETRATION; FIRST PASS EFFECT; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; STEADY STATE;

EID: 58149122682     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2008.10.023     Document Type: Article
Times cited : (19)

References (21)
  • 1
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon G.L., Lennernas H., Shah V.P., and Crison J.R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12 (1995) 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
  • 2
    • 0027141414 scopus 로고
    • Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies
    • Blume H.H., and Midha K.K. Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharm. Sci. 82 (1993) 1186-1189
    • (1993) J. Pharm. Sci. , vol.82 , pp. 1186-1189
    • Blume, H.H.1    Midha, K.K.2
  • 3
    • 0026017142 scopus 로고
    • The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect
    • Chen M.L., and Jackson A.J. The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect. Pharm. Res. 8 (1991) 25-32
    • (1991) Pharm. Res. , vol.8 , pp. 25-32
    • Chen, M.L.1    Jackson, A.J.2
  • 4
    • 0029077354 scopus 로고
    • The role of metabolites in bioequivalency assessment. II. Drugs with linear pharmacokinetics and first-pass effect
    • Chen M.L., and Jackson A.J. The role of metabolites in bioequivalency assessment. II. Drugs with linear pharmacokinetics and first-pass effect. Pharm. Res. 12 (1995) 700-708
    • (1995) Pharm. Res. , vol.12 , pp. 700-708
    • Chen, M.L.1    Jackson, A.J.2
  • 5
    • 0028060084 scopus 로고
    • Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations
    • el-Tahtawy A.A., Jackson A.J., and Ludden T.M. Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations. Pharm. Res. 11 (1994) 1330-1336
    • (1994) Pharm. Res. , vol.11 , pp. 1330-1336
    • el-Tahtawy, A.A.1    Jackson, A.J.2    Ludden, T.M.3
  • 6
    • 0029608829 scopus 로고
    • Evaluation of bioequivalence of highly variable drugs using Monte Carlo simulations. I. Estimation of rate of absorption for single and multiple dose trials using Cmax
    • el-Tahtawy A.A., Jackson A.J., and Ludden T.M. Evaluation of bioequivalence of highly variable drugs using Monte Carlo simulations. I. Estimation of rate of absorption for single and multiple dose trials using Cmax. Pharm. Res. 12 (1995) 1634-1641
    • (1995) Pharm. Res. , vol.12 , pp. 1634-1641
    • el-Tahtawy, A.A.1    Jackson, A.J.2    Ludden, T.M.3
  • 7
    • 0031913404 scopus 로고    scopus 로고
    • Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II. Comparison of single and multiple-dose trials using AUC and Cmax
    • el-Tahtawy A.A., Tozer T.N., Harrison F., Lesko L., and Williams R. Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II. Comparison of single and multiple-dose trials using AUC and Cmax. Pharm. Res. 15 (1998) 98-104
    • (1998) Pharm. Res. , vol.15 , pp. 98-104
    • el-Tahtawy, A.A.1    Tozer, T.N.2    Harrison, F.3    Lesko, L.4    Williams, R.5
  • 8
    • 58149111182 scopus 로고    scopus 로고
    • EMEA, 2001. CPMP/EWP/QWP/1401/98. Note for guidance on investigation of bioavailability and bioequivalence.
    • EMEA, 2001. CPMP/EWP/QWP/1401/98. Note for guidance on investigation of bioavailability and bioequivalence.
  • 9
    • 58149140460 scopus 로고    scopus 로고
    • EMEA, 2006. CHMP/EWP/40326/2006. Efficacy Working Party. Questions and Answers on the Bioavailability and Bioequivalence Guideline, pp. 1-5.
    • EMEA, 2006. CHMP/EWP/40326/2006. Efficacy Working Party. Questions and Answers on the Bioavailability and Bioequivalence Guideline, pp. 1-5.
  • 11
    • 58149132096 scopus 로고    scopus 로고
    • FDA, 2003. Guidance for industry bioavailability and bioequivalence studies for orally administered drug products-general considerations.
    • FDA, 2003. Guidance for industry bioavailability and bioequivalence studies for orally administered drug products-general considerations.
  • 12
    • 0023248387 scopus 로고
    • Prediction of steady-state bioequivalence relationships using single dose data I-linear kinetics
    • Jackson A.J. Prediction of steady-state bioequivalence relationships using single dose data I-linear kinetics. Biopharm. Drug Dispos. 8 (1987) 483-496
    • (1987) Biopharm. Drug Dispos. , vol.8 , pp. 483-496
    • Jackson, A.J.1
  • 13
    • 0024460011 scopus 로고
    • Prediction of steady state bioequivalence relationships using single dose data. II. Nonlinear kinetics
    • Jackson A.J. Prediction of steady state bioequivalence relationships using single dose data. II. Nonlinear kinetics. Biopharm. Drug Dispos. 10 (1989) 489-503
    • (1989) Biopharm. Drug Dispos. , vol.10 , pp. 489-503
    • Jackson, A.J.1
  • 14
    • 0034495152 scopus 로고    scopus 로고
    • The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and first-pass effect
    • Jackson A.J. The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and first-pass effect. Pharm. Res. 17 (2000) 1432-1436
    • (2000) Pharm. Res. , vol.17 , pp. 1432-1436
    • Jackson, A.J.1
  • 15
    • 0031720437 scopus 로고    scopus 로고
    • Assessment of metabolites in bioequivalence studies: should bioequivalence criteria be applied on the sum of parent compound and metabolite?
    • Mahmood I. Assessment of metabolites in bioequivalence studies: should bioequivalence criteria be applied on the sum of parent compound and metabolite?. Int. J. Clin. Pharmacol. Ther. 36 (1998) 540-544
    • (1998) Int. J. Clin. Pharmacol. Ther. , vol.36 , pp. 540-544
    • Mahmood, I.1
  • 16
    • 0031594862 scopus 로고    scopus 로고
    • Effects of variability in hepatic clearance on the bioequivalence parameters of a drug and its metabolite: simulations using a pharmacostatistical model
    • Rosenbaum S.E. Effects of variability in hepatic clearance on the bioequivalence parameters of a drug and its metabolite: simulations using a pharmacostatistical model. Pharm. Acta Helv. 73 (1998) 135-144
    • (1998) Pharm. Acta Helv. , vol.73 , pp. 135-144
    • Rosenbaum, S.E.1
  • 17
    • 0030898460 scopus 로고    scopus 로고
    • Bioequivalence parameters of parent drug and its first-pass metabolite: comparative sensitivity to sources of pharmacokinetic variability
    • Rosenbaum S.E., and Lam J. Bioequivalence parameters of parent drug and its first-pass metabolite: comparative sensitivity to sources of pharmacokinetic variability. Drug Dev. Ind. Pharm. 23 (1997) 337-344
    • (1997) Drug Dev. Ind. Pharm. , vol.23 , pp. 337-344
    • Rosenbaum, S.E.1    Lam, J.2
  • 19
    • 0011906896 scopus 로고
    • Metabolite measurement in bioequivalence studies: theoretical considerations
    • Midha K.K., and Blume H.H. (Eds), Medpharm Scientific Publishers, Stuttgart
    • Tucker G.T., Rostami-Hodjegan A., and Jackson P.R. Metabolite measurement in bioequivalence studies: theoretical considerations. In: Midha K.K., and Blume H.H. (Eds). Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics (1993), Medpharm Scientific Publishers, Stuttgart 163-170
    • (1993) Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics , pp. 163-170
    • Tucker, G.T.1    Rostami-Hodjegan, A.2    Jackson, P.R.3
  • 20
    • 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
    • Wu C.Y., and Benet L.Z. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm. Res. 22 (2005) 11-23
    • (2005) Pharm. Res. , vol.22 , pp. 11-23
    • Wu, C.Y.1    Benet, L.Z.2
  • 21
    • 0030898458 scopus 로고    scopus 로고
    • Variation of the peak concentration following single and repeated drug administrations in investigations of bioavailability and bioequivalence
    • Zha J., and Endrenyi L. Variation of the peak concentration following single and repeated drug administrations in investigations of bioavailability and bioequivalence. J. Biopharm. Stat. 7 (1997) 191-204
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 191-204
    • Zha, J.1    Endrenyi, L.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.