-
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
-
-
0033407634
-
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
-
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
-
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
-
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
-
-
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
-
-
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.
-
-
-
-
11
-
-
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
-
12
-
-
58149136674
-
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
22
-
-
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
-
23
-
-
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
-
24
-
-
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
-
25
-
-
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
|