-
1
-
-
0001668733
-
Bioavailability and bioequivalence requirements
-
Food and Drug Administration. Bioavailability and bioequivalence requirements. Fed. Regist. 42:1624-1653 (1977).
-
(1977)
Fed. Regist.
, vol.42
, pp. 1624-1653
-
-
-
2
-
-
0015902704
-
Use of statistical methods in evaluation of in vivo performance of dosage forms
-
W. J. Westlake. Use of statistical methods in evaluation of in vivo performance of dosage forms. J. Pharm. Sci. 62:1579-1589 (1973).
-
(1973)
J. Pharm. Sci.
, vol.62
, pp. 1579-1589
-
-
Westlake, W.J.1
-
3
-
-
0015379868
-
Use of confidence intervals in analysis of comparative bioavailability trials
-
W. J. Westlake. Use of confidence intervals in analysis of comparative bioavailability trials. J. Pharm. Sci. 61:1340-1341 (1972).
-
(1972)
J. Pharm. Sci.
, vol.61
, pp. 1340-1341
-
-
Westlake, W.J.1
-
4
-
-
3543004450
-
Bioavailability/Bioequivalence Regulations: An FDA Perspective
-
K. S. Albert (ed.), American Pharmaceutical Association Academy of Pharmaceutical Sciences, Washington, DC
-
E. Purich. Bioavailability/Bioequivalence Regulations: An FDA Perspective. In K. S. Albert (ed.), Drug Absorption and Disposition: Statistical Considerations, American Pharmaceutical Association Academy of Pharmaceutical Sciences, Washington, DC, 1980, pp. 115-137.
-
(1980)
Drug Absorption and Disposition: Statistical Considerations
, pp. 115-137
-
-
Purich, E.1
-
5
-
-
0026659546
-
A retrospective assessment of the 75/75 rule in bioequivalence
-
T. W. Dobbins and B. Thiyagarajan. A retrospective assessment of the 75/75 rule in bioequivalence. Stat. Med. 11:1333-1342 (1992).
-
(1992)
Stat. Med.
, vol.11
, pp. 1333-1342
-
-
Dobbins, T.W.1
Thiyagarajan, B.2
-
6
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:657-680 (1987).
-
(1987)
J. Pharmacokinet. Biopharm.
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
7
-
-
0027256110
-
Logarithmic transformation in bioequivalence - Application with 2 formulations of perphenazine
-
K. K. Midha, E. D. Ormsby, J. W. Hubbard, G. McKay, E. M. Hawes, L. Gavalas, and I. J. McGilveray. Logarithmic transformation in bioequivalence - application with 2 formulations of perphenazine. J. Pharm. Sci. 82:138-144 (1993).
-
(1993)
J. Pharm. Sci.
, vol.82
, pp. 138-144
-
-
Midha, K.K.1
Ormsby, E.D.2
Hubbard, J.W.3
McKay, G.4
Hawes, E.M.5
Gavalas, L.6
McGilveray, I.J.7
-
8
-
-
0026597801
-
Types of bioequivalence and related statistical considerations
-
W. W. Hauck and S. Anderson. Types of bioequivalence and related statistical considerations. Int. J. Clin. Pharm. Ther. Toxicol. 30:181-187 (1992).
-
(1992)
Int. J. Clin. Pharm. Ther. Toxicol.
, vol.30
, pp. 181-187
-
-
Hauck, W.W.1
Anderson, S.2
-
9
-
-
0026481178
-
Bioequivalence revisited
-
L. B. Sheiner. Bioequivalence revisited. Stat. Med. 11:1777-1788 (1992).
-
(1992)
Stat. Med.
, vol.11
, pp. 1777-1788
-
-
Sheiner, L.B.1
-
10
-
-
0024267609
-
Initial slope technique to estimate first- and zero-order drug absorption rate constants
-
J. G. Zhi. Initial slope technique to estimate first- and zero-order drug absorption rate constants. J. Pharm. Sci. 77:816-817 (1988).
-
(1988)
J. Pharm. Sci.
, vol.77
, pp. 816-817
-
-
Zhi, J.G.1
-
11
-
-
0023858202
-
An area function method for estimating the apparent absorption rate constant
-
H. Cheng, A. E. Staubus, and L. Shum. An area function method for estimating the apparent absorption rate constant. Pharm. Res. 5:57-60 (1988).
-
(1988)
Pharm. Res.
, vol.5
, pp. 57-60
-
-
Cheng, H.1
Staubus, A.E.2
Shum, L.3
-
12
-
-
0030060434
-
Tmax: An unconfounded metric for rate of absorption in single dose bioequivalence studies
-
R. P. Basson, B. J. Cerimele, K. A. Desante, and D. C. Howey. Tmax: an unconfounded metric for rate of absorption in single dose bioequivalence studies. Pharm. Res. 13:324-328 (1996).
-
(1996)
Pharm. Res.
, vol.13
, pp. 324-328
-
-
Basson, R.P.1
Cerimele, B.J.2
Desante, K.A.3
Howey, D.C.4
-
13
-
-
0025918379
-
Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence
-
L. Endrenyi, S. Fritsch, and W. Yan. Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence. Int. J. Clin. Pharm. Ther. Toxicol. 29:394-399 (1991).
-
(1991)
Int. J. Clin. Pharm. Ther. Toxicol.
, vol.29
, pp. 394-399
-
-
Endrenyi, L.1
Fritsch, S.2
Yan, W.3
-
14
-
-
0027987256
-
Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies - Moving the "goalposts" or changing the "game"
-
A. Rostamihodjegan, P. R. Jackson, and G. T. Tucker. Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies - moving the "goalposts" or changing the "game". J. Pharm. Sci. 83:1554-1557 (1994).
-
(1994)
J. Pharm. Sci.
, vol.83
, pp. 1554-1557
-
-
Rostamihodjegan, A.1
Jackson, P.R.2
Tucker, G.T.3
-
15
-
-
0035659563
-
Bioavailability and bioequivalence: An FDA regulatory overview
-
M. L. Chen, V. Shah, R. Patnaik, W. Adams, A. Hussain, D. Conner, M. Mehta, H. Malinowski, J. Lazor, S. M. Huang, D. Hare, L. Lesko, D. Sporn, and R. Williams. Bioavailability and bioequivalence: An FDA regulatory overview. Pharm. Res. 18: 1645-1650 (2001).
-
(2001)
Pharm. Res.
, vol.18
, pp. 1645-1650
-
-
Chen, M.L.1
Shah, V.2
Patnaik, R.3
Adams, W.4
Hussain, A.5
Conner, D.6
Mehta, M.7
Malinowski, H.8
Lazor, J.9
Huang, S.M.10
Hare, D.11
Lesko, L.12
Sporn, D.13
Williams, R.14
-
19
-
-
0031947633
-
Drug interactions at the renal level: Implications for drug development
-
P. L. Bonate, K. Reith, and S. Weir. Drug interactions at the renal level: Implications for drug development. Clin. Pharmacokinet. 34:375-404 (1998).
-
(1998)
Clin. Pharmacokinet.
, vol.34
, pp. 375-404
-
-
Bonate, P.L.1
Reith, K.2
Weir, S.3
-
20
-
-
0035693563
-
Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making
-
J. V. S. Gobburu and P. J. Marroum. Utilisation of pharmacokinetic- pharmacodynamic modelling and simulation in regulatory decision-making. Clin. Pharmacokinet. 40:883-892 (2001).
-
(2001)
Clin. Pharmacokinet.
, vol.40
, pp. 883-892
-
-
Gobburu, J.V.S.1
Marroum, P.J.2
-
21
-
-
0028802280
-
Studies of the oral bioavailability of alendronate
-
B. J. Gertz, S. H. Holland, W. F. Kline, B. K. Matuszewski, A. Freeman, H. Quan, K. C. Lasseter, J. C. Mucklow, and A. G. Porras. Studies of the oral bioavailability of alendronate. Clin. Pharmacol. Ther. 58:288-298 (1995).
-
(1995)
Clin. Pharmacol. Ther.
, vol.58
, pp. 288-298
-
-
Gertz, B.J.1
Holland, S.H.2
Kline, W.F.3
Matuszewski, B.K.4
Freeman, A.5
Quan, H.6
Lasseter, K.C.7
Mucklow, J.C.8
Porras, A.G.9
-
23
-
-
0032847790
-
The effect of dosing regimen on the pharmacokinetics of risedronate
-
D. Y. Mitchell, M. A. Heise, K. A. Pallone, M. E. Clay, J. D. Nesbitt, D. A. Russell, and C. W. Melson. The effect of dosing regimen on the pharmacokinetics of risedronate. Brit. J. Clin. Pharmacol. 48:536-542 (1999).
-
(1999)
Brit. J. Clin. Pharmacol.
, vol.48
, pp. 536-542
-
-
Mitchell, D.Y.1
Heise, M.A.2
Pallone, K.A.3
Clay, M.E.4
Nesbitt, J.D.5
Russell, D.A.6
Melson, C.W.7
-
24
-
-
0034145470
-
Dose-proportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers
-
D. Y. Mitchell, R. A. Eusebio, N. A. Sacco-Gibson, K. A. Pallone, S. C. Kelly, J. D. Nesbitt, C. P. Brezovic, G. A. Thompson, and J. H. Powell. Dose-proportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers. J. Clin. Pharmacol. 40:258-265 (2000).
-
(2000)
J. Clin. Pharmacol.
, vol.40
, pp. 258-265
-
-
Mitchell, D.Y.1
Eusebio, R.A.2
Sacco-Gibson, N.A.3
Pallone, K.A.4
Kelly, S.C.5
Nesbitt, J.D.6
Brezovic, C.P.7
Thompson, G.A.8
Powell, J.H.9
-
26
-
-
84939683797
-
Renal excretion of drugs and other xenobiotics
-
K. Besseghir and F. Roch-Ramel. Renal excretion of drugs and other xenobiotics. Renal Physiol. 10:221-241 (1987).
-
(1987)
Renal Physiol.
, vol.10
, pp. 221-241
-
-
Besseghir, K.1
Roch-Ramel, F.2
-
27
-
-
0025221658
-
Nonlinear kinetics of the thiamine cation in humans: Saturation of nonrenal clearance and tubular reabsorption
-
W. Weber, M. Nitz, and M. Looby. Nonlinear kinetics of the thiamine cation in humans: Saturation of nonrenal clearance and tubular reabsorption. J. Pharmacokinet. Biopharm. 18:501-523 (1990).
-
(1990)
J. Pharmacokinet. Biopharm.
, vol.18
, pp. 501-523
-
-
Weber, W.1
Nitz, M.2
Looby, M.3
-
28
-
-
0026338967
-
System analysis in multiple dose kinetics: Evidence for saturable tubular reabsorption of the organic cation N1-methylnicotinamide in humans
-
W. Weber, S. Toussaint, M. Looby, M. Nitz, and H. Kewitz. System analysis in multiple dose kinetics: Evidence for saturable tubular reabsorption of the organic cation N1-methylnicotinamide in humans. J. Pharmacokinet. Biopharm. 19:553-574 (1990).
-
(1990)
J. Pharmacokinet. Biopharm.
, vol.19
, pp. 553-574
-
-
Weber, W.1
Toussaint, S.2
Looby, M.3
Nitz, M.4
Kewitz, H.5
-
29
-
-
0024548255
-
Saturable pharmacokinetics in the renal excretion of drugs
-
C. A. M. Van Ginneken and F. G. M. Russel. Saturable pharmacokinetics in the renal excretion of drugs. Clin. Pharmacokinet. 16:38-54 (1989).
-
(1989)
Clin. Pharmacokinet.
, vol.16
, pp. 38-54
-
-
Van Ginneken, C.A.M.1
Russel, F.G.M.2
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