메뉴 건너뛰기




Volumn 36, Issue 1, 2009, Pages 137-146

Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Linear kinetics (I)

Author keywords

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

Indexed keywords

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

EID: 58149129024     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2008.10.014     Document Type: Article
Times cited : (21)

References (25)
  • 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
    • 0033407634 scopus 로고    scopus 로고
    • The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?
    • Blume H.H., and Schug B.S. The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?. Eur J. Pharm. Sci. 9 (1999) 117-121
    • (1999) Eur J. Pharm. Sci. , vol.9 , pp. 117-121
    • Blume, H.H.1    Schug, B.S.2
  • 4
    • 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
  • 5
    • 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
  • 6
    • 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
  • 9
    • 58149134609 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.
  • 10
    • 58149134605 scopus 로고    scopus 로고
    • EMEA, 2006. CHMP/EWP/40326/2006 Efficacy Working Party. Questions and Answers on the Bioavailability and Bioequivalence Guideline.
    • EMEA, 2006. CHMP/EWP/40326/2006 Efficacy Working Party. Questions and Answers on the Bioavailability and Bioequivalence Guideline.
  • 12
    • 58149136674 scopus 로고    scopus 로고
    • FDA, 2000. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.
    • FDA, 2000. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.
  • 13
    • 58149108062 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.
  • 14
    • 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 Disposition 8 (1987) 483-496
    • (1987) Biopharm. Drug Disposition , vol.8 , pp. 483-496
    • Jackson, A.J.1
  • 15
    • 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 Disposition 10 (1989) 489-503
    • (1989) Biopharm. Drug Disposition , vol.10 , pp. 489-503
    • Jackson, A.J.1
  • 16
    • 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
  • 17
    • 33846481265 scopus 로고    scopus 로고
    • Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination rates
    • Kortejarvi H., Urtti A., and Yliperttula M. Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination rates. Eur J. Pharm. Sci. 30 (2007) 155-166
    • (2007) Eur J. Pharm. Sci. , vol.30 , pp. 155-166
    • Kortejarvi, H.1    Urtti, A.2    Yliperttula, M.3
  • 18
    • 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
  • 19
    • 0030926727 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets
    • Polli J.E., Rekhi G.S., Augsburger L.L., and Shah V.P. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86 (1997) 690-700
    • (1997) J. Pharm. Sci. , vol.86 , pp. 690-700
    • Polli, J.E.1    Rekhi, G.S.2    Augsburger, L.L.3    Shah, V.P.4
  • 20
    • 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
  • 21
    • 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
  • 23
    • 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
  • 24
    • 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
  • 25
    • 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.