-
1
-
-
0028948839
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
-
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.
-
-
-
-
10
-
-
0030070953
-
Bioequivalence study of alpha-dihydroergocryptine: utility of metabolite evaluation
-
Ezan E., Ardouin T., Delhotal Landes B., Flouvat B., Hanslik T., Legeai J.M., and Grognet J.M. Bioequivalence study of alpha-dihydroergocryptine: utility of metabolite evaluation. Int. J. Clin. Pharmacol. Ther. 34 (1996) 32-37
-
(1996)
Int. J. Clin. Pharmacol. Ther.
, vol.34
, pp. 32-37
-
-
Ezan, E.1
Ardouin, T.2
Delhotal Landes, B.3
Flouvat, B.4
Hanslik, T.5
Legeai, J.M.6
Grognet, J.M.7
-
11
-
-
58149132096
-
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
18
-
-
58149128081
-
Bioequivalence-a measure of therapeutic equivalence?
-
Midha K.K., and Blume H.H. (Eds), Medpharm Scientific Publishers, Stuttgart
-
Tucker G.T., Rostami-Hodjegan A., and Jackson P.R. Bioequivalence-a measure of therapeutic equivalence?. In: Midha K.K., and Blume H.H. (Eds). Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics (1993), Medpharm Scientific Publishers, Stuttgart 35-43
-
(1993)
Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics
, pp. 35-43
-
-
Tucker, G.T.1
Rostami-Hodjegan, A.2
Jackson, P.R.3
-
19
-
-
0011906896
-
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
-
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
-
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
|