-
1
-
-
0027987256
-
Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies - Moving the "goalposts" or changing the "game"
-
1. A. Rostami-Hodjegan, 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
-
-
Rostami-Hodjegan, A.1
Jackson, P.R.2
Tucker, G.T.3
-
2
-
-
0028226203
-
Bioequivalence: Performance of several measures of rate of absorption
-
2. F. Y. Bois, T. N. Tozer, W. W. Hauck, M.-L. Chen, R. Patnaik, and R. L. Williams. Bioequivalence: performance of several measures of rate of absorption. Pharm. Res. 11:966-974 (1994).
-
(1994)
Pharm. Res.
, vol.11
, pp. 966-974
-
-
Bois, F.Y.1
Tozer, T.N.2
Hauck, W.W.3
Chen, M.-L.4
Patnaik, R.5
Williams, R.L.6
-
3
-
-
0029611221
-
Sensitive and specific determination of the equivalence of absorption rates
-
3. L. Endrenyi and P. Al-Shaikh. Sensitive and specific determination of the equivalence of absorption rates. Pharm. Res. 12:1856-1864 (1995).
-
(1995)
Pharm. Res.
, vol.12
, pp. 1856-1864
-
-
Endrenyi, L.1
Al-Shaikh, P.2
-
5
-
-
0029940802
-
Absorption rate vs. exposure: Which is more useful for bioequivalence testing?
-
5. T. N. Tozer, F. Y. Bois, W. W. Hauck, M.-L. Chen, and R. L. Williams. Absorption rate vs. exposure: which is more useful for bioequivalence testing? Pharm. Res. 13:453-456 (1996).
-
(1996)
Pharm. Res.
, vol.13
, pp. 453-456
-
-
Tozer, T.N.1
Bois, F.Y.2
Hauck, W.W.3
Chen, M.-L.4
Williams, R.L.5
-
6
-
-
0028889006
-
Evaluation of different metrics and indirect measures of rate of drug absorption from extended release dosage forms at steady-state
-
6. C. Reppas, L. F. Lacey, O. N. Keene, P. Macheras, and A. Bye. Evaluation of different metrics and indirect measures of rate of drug absorption from extended release dosage forms at steady-state. Pharm. Res. 12:103-107 (1995).
-
(1995)
Pharm. Res.
, vol.12
, pp. 103-107
-
-
Reppas, C.1
Lacey, L.F.2
Keene, O.N.3
Macheras, P.4
Bye, A.5
-
7
-
-
0031944438
-
The duration of measuring partial AUCs for the assessment of bioequivalence
-
7. L. Endrenyi, F. Csizmadia, L. Tothfalusi, A. H. Balch, and M.-L. Chen. The duration of measuring partial AUCs for the assessment of bioequivalence. Pharm. Res. 15:399-404 (1998).
-
(1998)
Pharm. Res.
, vol.15
, pp. 399-404
-
-
Endrenyi, L.1
Csizmadia, F.2
Tothfalusi, L.3
Balch, A.H.4
Chen, M.-L.5
-
8
-
-
0031689198
-
Metrics comparing early concentration profiles for the determination of bioequivalence
-
8. L. Endrenyi, F. Csizmadia, L. Tothfalusi, and M.-L. Chen. Metrics comparing early concentration profiles for the determination of bioequivalence. Pharm. Res. 15:1292-1299 (1998).
-
(1998)
Pharm. Res.
, vol.15
, pp. 1292-1299
-
-
Endrenyi, L.1
Csizmadia, F.2
Tothfalusi, L.3
Chen, M.-L.4
-
9
-
-
0004713950
-
-
Draft Guidance, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD, August
-
9. Food and Drug Administration. "Guidance for Industry: BA and BE Studies for Orally Administered Drug Products-General Considerations". Draft Guidance, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD, August, 1999.
-
(1999)
Guidance for Industry: BA and BE Studies for Orally Administered Drug Products - General Considerations
-
-
-
10
-
-
0029973918
-
A novel extravascular input function for the assessment of drug absorption in bioavailability studies
-
10. M. Weiss. A novel extravascular input function for the assessment of drug absorption in bioavailability studies. Pharm. Res. 13:1545-1551 (1996).
-
(1996)
Pharm. Res.
, vol.13
, pp. 1545-1551
-
-
Weiss, M.1
-
11
-
-
18544402304
-
Pharmacokinetic modeling of M6G formation after oral administration of morphine in healthy volunteers
-
11. J. Loetsch, M. Weiss, G. Ahne, G. Kobal, and G. Geisslinger. Pharmacokinetic modeling of M6G formation after oral administration of morphine in healthy volunteers. Anesthesiology 90:1026-38 (1999).
-
(1999)
Anesthesiology
, vol.90
, pp. 1026-1038
-
-
Loetsch, J.1
Weiss, M.2
Ahne, G.3
Kobal, G.4
Geisslinger, G.5
-
12
-
-
0029926360
-
Mean input times of three oral chlorprothixene formulations
-
12. M. Bagli, R. Suverkrup, M. L. Rao, and H. Bode. Mean input times of three oral chlorprothixene formulations. J. Pharm. Sci. 85:434-439 (1996).
-
(1996)
J. Pharm. Sci.
, vol.85
, pp. 434-439
-
-
Bagli, M.1
Suverkrup, R.2
Rao, M.L.3
Bode, H.4
-
13
-
-
0031977427
-
Model-independent estimation of lag-times with first-order absorption and disposition
-
13. F. Csizmadia and L. Endrenyi. Model-independent estimation of lag-times with first-order absorption and disposition. J. Pharm. Sci. 87:608-612 (1998).
-
(1998)
J. Pharm. Sci.
, vol.87
, pp. 608-612
-
-
Csizmadia, F.1
Endrenyi, L.2
-
14
-
-
0031457483
-
On the degree of solute mixing in liver models of drug elimination
-
14. M. Weiss. On the degree of solute mixing in liver models of drug elimination, J. Pharmacokin. Biopharm. 25:363-375 (1997).
-
(1997)
J. Pharmacokin. Biopharm.
, vol.25
, pp. 363-375
-
-
Weiss, M.1
-
15
-
-
0027172393
-
The impact of lag time on the estimation of pharmacokinetic parameters. I. One-compartment open model
-
15. N. G. Nerella, L. H. Block, and P. K. Noonan. The impact of lag time on the estimation of pharmacokinetic parameters. I. One-compartment open model. Pharm. Res. 10:1031-1036 (1993).
-
(1993)
Pharm. Res.
, vol.10
, pp. 1031-1036
-
-
Nerella, N.G.1
Block, L.H.2
Noonan, P.K.3
-
16
-
-
0026488257
-
An alternative approach for assessment of rate of absorption in bioequivalence studies
-
16. M.-L. Chen. An alternative approach for assessment of rate of absorption in bioequivalence studies. Pharm. Res. 9:1380-1385 (1992).
-
(1992)
Pharm. Res.
, vol.9
, pp. 1380-1385
-
-
Chen, M.-L.1
-
17
-
-
0030455294
-
An improved intercept method for the assessment of absorption rate in bioequivalence studies
-
17. P. Macheras, M. Symillides, and C. Reppas. An improved intercept method for the assessment of absorption rate in bioequivalence studies. Pharm. Res. 13:1755-1758 (1996).
-
(1996)
Pharm. Res.
, vol.13
, pp. 1755-1758
-
-
Macheras, P.1
Symillides, M.2
Reppas, C.3
-
18
-
-
0029135205
-
Properties of metrics applied for the evaluation of bioequivalence
-
18. J. Zha, L. Tothfalusi, and L. Endrenyi. Properties of metrics applied for the evaluation of bioequivalence. Drug Info. J. 29:989-996 (1995).
-
(1995)
Drug Info. J.
, vol.29
, pp. 989-996
-
-
Zha, J.1
Tothfalusi, L.2
Endrenyi, L.3
-
20
-
-
0031917671
-
Why rate of absorption inferences in single dose bioequivalence studies are often inappropriate
-
20. R. P. Basson, A. Ghosh, B. J. Cerimele, K. A. DeSante, and D. C. Howe. Why rate of absorption inferences in single dose bioequivalence studies are often inappropriate. Pharm. Res. 15:276-279 (1998).
-
(1998)
Pharm. Res.
, vol.15
, pp. 276-279
-
-
Basson, R.P.1
Ghosh, A.2
Cerimele, B.J.3
DeSante, K.A.4
Howe, D.C.5
-
21
-
-
0024913320
-
Power analyses of moment analysis in bioequivalence tests
-
21. N. Kaniwa, H. Ogata, N. Aoyagi, T. Takeda, and M. Uchiyama. Power analyses of moment analysis in bioequivalence tests. J. Pharm. Sci. 78:1020-1024 (1989).
-
(1989)
J. Pharm. Sci.
, vol.78
, pp. 1020-1024
-
-
Kaniwa, N.1
Ogata, H.2
Aoyagi, N.3
Takeda, T.4
Uchiyama, M.5
|