-
1
-
-
14844291495
-
-
Rockville, MD, Sept.
-
US Food and Drug Administration, Guidance for Industry: PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, Sept. 2004), http://www.fda.gov/cder/guidance/index.htm, accessed May 5, 2006.
-
(2004)
Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
-
-
-
3
-
-
33748929894
-
-
International Conference on Harmonization draft no. 4.3: Step 2, Nov.
-
J. Berridge, Q8 Pharmaceutical Development, International Conference on Harmonization draft no. 4.3: Step 2, Nov. 2004, http://www.fda.gov/cder/ guidance/index.htm, accessed May 5, 2006.
-
(2004)
Q8 Pharmaceutical Development
-
-
Berridge, J.1
-
4
-
-
0040874192
-
Granulation in different types of high-speed mixers, part I: Effects of process variables and up-scaling
-
T. Schaefer et al., "Granulation in Different Types of High-Speed Mixers, Part I: Effects of Process Variables and Up-Scaling," Pharm. Ind. 48 (9), 1083-1089 (1986).
-
(1986)
Pharm. Ind.
, vol.48
, Issue.9
, pp. 1083-1089
-
-
Schaefer, T.1
-
5
-
-
0020760525
-
Use of a fractional factorial design to evaluate granulations prepared in a fluidized bed
-
M. Meshali, H. El-Banna, and H. El-Sabbagh, "Use of a Fractional Factorial Design to Evaluate Granulations Prepared in a Fluidized Bed," Pharmazie 38 (5), 323-325 (1983).
-
(1983)
Pharmazie
, vol.38
, Issue.5
, pp. 323-325
-
-
Meshali, M.1
El-Banna, H.2
El-Sabbagh, H.3
-
6
-
-
0000745430
-
-
Marcel Dekker, New York NY, 2nd ed.
-
H. Lieberman, L. Lachman, and J. Schwartz, Pharmaceutical Dosage Forms: Tablets Vol. 2 (Marcel Dekker, New York NY, 2nd ed., 1990), pp. 245-348.
-
(1990)
Pharmaceutical Dosage Forms: Tablets
, vol.2
, pp. 245-348
-
-
Lieberman, H.1
Lachman, L.2
Schwartz, J.3
-
7
-
-
0036025247
-
Scale-up and end point issues of pharmaceutical wet granulation in a V-type low-shear granulator
-
T. Chirkot, "Scale-Up and End Point Issues of Pharmaceutical Wet Granulation in a V-Type Low-Shear Granulator," Drug Dev. Ind. Pharm. 28 (7), 871-888 (2002).
-
(2002)
Drug Dev. Ind. Pharm.
, vol.28
, Issue.7
, pp. 871-888
-
-
Chirkot, T.1
-
8
-
-
23144437558
-
Effects of drug substance particle size on the characteristics of granulation manufactured in a high-shear mixer
-
article 33
-
S. Badawy, T. Lee, and M. Menning, "Effects of Drug Substance Particle Size on the Characteristics of Granulation Manufactured in a High-Shear Mixer," AAPS PharmSciTech 1 (4), article 33 (2000).
-
(2000)
AAPS PharmSciTech
, vol.1
, Issue.4
-
-
Badawy, S.1
Lee, T.2
Menning, M.3
-
10
-
-
0035010162
-
End-point detection in a wet granulation process
-
P. Holm, T. Schaefer, and C. Larsen, "End-Point Detection in a Wet Granulation Process," Pharm. Dev. Technol. 6 (2), 181-192 (2001).
-
(2001)
Pharm. Dev. Technol.
, vol.6
, Issue.2
, pp. 181-192
-
-
Holm, P.1
Schaefer, T.2
Larsen, C.3
-
11
-
-
0026793762
-
Monitoring the granulation process in a high-shear mixer-granulator: An evaluation of three approaches to instrumentation
-
M. Kopcha, G. Roland, and W. Vading, "Monitoring the Granulation Process in a High-Shear Mixer-Granulator: An Evaluation of Three Approaches to Instrumentation," Drug Dev. Ind. Pharm. 18 (18), 1945-1968 (1992).
-
(1992)
Drug Dev. Ind. Pharm.
, vol.18
, Issue.18
, pp. 1945-1968
-
-
Kopcha, M.1
Roland, G.2
Vading, W.3
-
12
-
-
0002717342
-
A new approach to scale-up of a high-shear granulation process
-
Oct.
-
L.L. Augsburger et al., "A New Approach to Scale-Up of a High-Shear Granulation Process," Pharm. Technol. (supplement), 2-10 (Oct. 1996).
-
(1996)
Pharm. Technol.
, Issue.SUPPL.
, pp. 2-10
-
-
Augsburger, L.L.1
-
13
-
-
0025100556
-
Analysis of end point with power consumption in a high-speed mixer
-
K. Terashita et al., "Analysis of End Point with Power Consumption in a High-Speed Mixer," Chem. Pharm. Bull. 38 (7), 1977-1982 (1990).
-
(1990)
Chem. Pharm. Bull.
, vol.38
, Issue.7
, pp. 1977-1982
-
-
Terashita, K.1
-
15
-
-
26844482760
-
Process control and scale-up of high-shear wet granulation
-
A. Royce et al., "Process Control and Scale-Up of High-Shear Wet Granulation," J. Proc. Anal. Technol. 2 (2), 8-16 (2005).
-
(2005)
J. Proc. Anal. Technol.
, vol.2
, Issue.2
, pp. 8-16
-
-
Royce, A.1
-
16
-
-
5444227843
-
Granulation and scale-up issues in solid dosage form development
-
T. Hlinak, "Granulation and Scale-Up Issues in Solid Dosage Form Development," Am. Pharm. Rev. 3 (4), 33-36 (2000).
-
(2000)
Am. Pharm. Rev.
, vol.3
, Issue.4
, pp. 33-36
-
-
Hlinak, T.1
-
17
-
-
0036332065
-
Monitoring blend uniformity with effusivity
-
N. Mathis et al., "Monitoring Blend Uniformity with Effusivity," Pharm. Technol. 26 (4), 80-84 (2002).
-
(2002)
Pharm. Technol.
, vol.26
, Issue.4
, pp. 80-84
-
-
Mathis, N.1
-
19
-
-
0032783419
-
Effects of high-shear granulation on granulate homogeneity
-
H. Vromans, H. Poels-Janssen, and H. Egermann, "Effects of High-Shear Granulation on Granulate Homogeneity," Pharm. Dev. Technol. 4 (3), 297-303 (1999).
-
(1999)
Pharm. Dev. Technol.
, vol.4
, Issue.3
, pp. 297-303
-
-
Vromans, H.1
Poels-Janssen, H.2
Egermann, H.3
-
20
-
-
0033010179
-
Evaluation of blend sampling errors: A statistical approach
-
R. Hwang, Y. Huang, and G. Peck, "Evaluation of Blend Sampling Errors: A Statistical Approach," Pharm. Technol. 23 (6), 56-65 (1999).
-
(1999)
Pharm. Technol.
, vol.23
, Issue.6
, pp. 56-65
-
-
Hwang, R.1
Huang, Y.2
Peck, G.3
|