-
1
-
-
84884966192
-
Historical development of dissolution testing
-
Taylor & Francis Group, New York, J. Dressman, J. Krämer (Eds.)
-
Krämer J., Grady L.T., Gajendran J. Historical development of dissolution testing. Pharmaceutical Dissolution Testing 2005, 1-38. Taylor & Francis Group, New York. J. Dressman, J. Krämer (Eds.).
-
(2005)
Pharmaceutical Dissolution Testing
, pp. 1-38
-
-
Krämer, J.1
Grady, L.T.2
Gajendran, J.3
-
2
-
-
78149497359
-
-
US Pharmacopeial Forum, Pharmacopeial Previews,
-
US Pharmacopeial Forum, Pharmacopeial Previews, vol. 30, 2004, pp. 351-363.
-
(2004)
, vol.30
, pp. 351-363
-
-
-
4
-
-
0003701605
-
-
Food and Drug Administration, Rockville, MD, FDA
-
FDA Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of in vitro/in vivo Correlations 1997, Food and Drug Administration, Rockville, MD.
-
(1997)
Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of in vitro/in vivo Correlations
-
-
-
5
-
-
0033805179
-
In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs
-
Dressman J.B., Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur. J. Pharm. Sci. 2000, 11:73-80.
-
(2000)
Eur. J. Pharm. Sci.
, vol.11
, pp. 73-80
-
-
Dressman, J.B.1
Reppas, C.2
-
6
-
-
0035858365
-
Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations
-
Uppoor V.R.S. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J. Control. Release 2001, 72:127-132.
-
(2001)
J. Control. Release
, vol.72
, pp. 127-132
-
-
Uppoor, V.R.S.1
-
7
-
-
44949089872
-
-
In vitro-in vivo correlation: importance of dissolution in IVIVC, Dissolution Technologies,
-
J.M. Cardot, E. Beyssac, M. Alric, In vitro-in vivo correlation: importance of dissolution in IVIVC, Dissolution Technologies, 2007, pp. 15-19.
-
(2007)
, pp. 15-19
-
-
Cardot, J.M.1
Beyssac, E.2
Alric, M.3
-
9
-
-
0035997152
-
Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers
-
Falcoz C., Jenkins J.M., Bye C., Hardman T.C., Kenney K.B., Studenberg S., Fuder H., Prince W.T.J. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. Clin. Pharmacol. 2002, 42:887-898.
-
(2002)
Clin. Pharmacol.
, vol.42
, pp. 887-898
-
-
Falcoz, C.1
Jenkins, J.M.2
Bye, C.3
Hardman, T.C.4
Kenney, K.B.5
Studenberg, S.6
Fuder, H.7
Prince, W.T.J.8
-
10
-
-
10744226866
-
Preclinical pharmacology and pharmacokinetics of GW433908, a water-soluble prodrug of the human immunodeficiency virus protease inhibitor amprenavir
-
Furfine E.S., Baker C.T., Hale M.R., Reynolds D.J., Salisbury J.A., Searle A.D., Studenberg S.D., Todd D., Tung R.D., Spaltenstein A. Preclinical pharmacology and pharmacokinetics of GW433908, a water-soluble prodrug of the human immunodeficiency virus protease inhibitor amprenavir. Antimicrob. Agents Chemother. 2004, 48:791-798.
-
(2004)
Antimicrob. Agents Chemother.
, vol.48
, pp. 791-798
-
-
Furfine, E.S.1
Baker, C.T.2
Hale, M.R.3
Reynolds, D.J.4
Salisbury, J.A.5
Searle, A.D.6
Studenberg, S.D.7
Todd, D.8
Tung, R.D.9
Spaltenstein, A.10
-
12
-
-
84855623929
-
-
EMEA, European Medicines Agency,
-
EMEA, European Medicines Agency, 2009, http://www.emea.europa.eu/humandocs/PDFs/EPAR/telzir/H-534-PI-en.pdf.
-
(2009)
-
-
-
13
-
-
0028948839
-
A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability
-
Amidon G.L., Lennernäs H., Shah V.P., Crison J.R. A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995, 12:413-420.
-
(1995)
Pharm. Res.
, vol.12
, pp. 413-420
-
-
Amidon, G.L.1
Lennernäs, H.2
Shah, V.P.3
Crison, J.R.4
-
14
-
-
84855630374
-
-
FDA, Food and Drug Administration, .
-
FDA, Food and Drug Administration, http://www.accessdata.fda.gov/scripts/cder/dissolution.
-
-
-
-
15
-
-
9144240623
-
Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients
-
Wood R., Arasteh K., Stelbrink H., Teofilo E., Raffi F., Pollard R., Yeo J., Wire M.b. Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients. Antimicrob. Agents Chemother. 2004, 48:116-123.
-
(2004)
Antimicrob. Agents Chemother.
, vol.48
, pp. 116-123
-
-
Wood, R.1
Arasteh, K.2
Stelbrink, H.3
Teofilo, E.4
Raffi, F.5
Pollard, R.6
Yeo, J.7
Wire, M.8
-
18
-
-
78149497398
-
-
ICH, Validation of analytical procedures: text and methodology (Q2R1), in: International Conference on Harmonization, Geneva,
-
ICH, Validation of analytical procedures: text and methodology (Q2R1), in: International Conference on Harmonization, Geneva, 2005.
-
(2005)
-
-
-
20
-
-
0035073301
-
Modeling and comparison of dissolution profiles
-
Costa P., Lobo J.M.S. Modeling and comparison of dissolution profiles. Eur. J. Pharm. Sci. 2001, 13:123-133.
-
(2001)
Eur. J. Pharm. Sci.
, vol.13
, pp. 123-133
-
-
Costa, P.1
Lobo, J.M.S.2
-
21
-
-
0034846201
-
Guidelines on dissolution profile comparison
-
Freitag G. Guidelines on dissolution profile comparison. Drug Inf. J. 2001, 35:865-874.
-
(2001)
Drug Inf. J.
, vol.35
, pp. 865-874
-
-
Freitag, G.1
-
22
-
-
0029828547
-
Methods to compare dissolution profiles
-
Shah V.P., Polli J.E. Methods to compare dissolution profiles. Drug Inf. J. 1996, 30:1113-1120.
-
(1996)
Drug Inf. J.
, vol.30
, pp. 1113-1120
-
-
Shah, V.P.1
Polli, J.E.2
-
23
-
-
33745616771
-
In vitro-in vivo correlation: from theory to applications
-
Emami F. In vitro-in vivo correlation: from theory to applications. J. Pharm. Pharmaceut. Sci. 2006, 9:169-189.
-
(2006)
J. Pharm. Pharmaceut. Sci.
, vol.9
, pp. 169-189
-
-
Emami, F.1
-
24
-
-
10344257263
-
Acceptable analytical practices for dissolution testing of poorly soluble compounds
-
Brown C.K., Chokshi H.P., Nickerson B., Reed R.A., Rohrs B.R., Shah P.A. Acceptable analytical practices for dissolution testing of poorly soluble compounds. Pharm. Technol. 2004, 56-65.
-
(2004)
Pharm. Technol.
, pp. 56-65
-
-
Brown, C.K.1
Chokshi, H.P.2
Nickerson, B.3
Reed, R.A.4
Rohrs, B.R.5
Shah, P.A.6
|