-
1
-
-
79954514861
-
-
Food and Drug Administration. Final report on pharmaceutical cGMPs for the 21st century-a risk-based approach.
-
Food and Drug Administration. 2003. Final report on pharmaceutical cGMPs for the 21st century-a risk-based approach.
-
(2003)
-
-
-
2
-
-
43349088601
-
Pharmaceutical quality by design: Product and process development, understanding, and control
-
Yu L. 2008. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharm Res 25:781-791.
-
(2008)
Pharm Res
, vol.25
, pp. 781-791
-
-
Yu, L.1
-
3
-
-
62649115024
-
Functionality and performance of excipients in a quality-by-design world part 2: Excipient variability, QbD, and robust formulations
-
Moreton C. 2009. Functionality and performance of excipients in a quality-by-design world part 2: Excipient variability, QbD, and robust formulations. Am Pharm Rev 12:40-45.
-
(2009)
Am Pharm Rev
, vol.12
, pp. 40-45
-
-
Moreton, C.1
-
4
-
-
77649189829
-
Tableting process optimization with the application of fuzzy models
-
Belic A, Skrjanc I, Bozic DZ, Vrecer F. 2010. Tableting process optimization with the application of fuzzy models. Int J Pharm 389:86-93.
-
(2010)
Int J Pharm
, vol.389
, pp. 86-93
-
-
Belic, A.1
Skrjanc, I.2
Bozic, D.Z.3
Vrecer, F.4
-
5
-
-
70350208809
-
Quality by design case study: An integrated multivariate approach to drug product and process development
-
Huang J, Kaul G, Cai C, Chatlapalli R, Hernandez-Abad P, Ghosh K, Nagi A. 2009. Quality by design case study: An integrated multivariate approach to drug product and process development. Int J Pharm 382:23-32.
-
(2009)
Int J Pharm
, vol.382
, pp. 23-32
-
-
Huang, J.1
Kaul, G.2
Cai, C.3
Chatlapalli, R.4
Hernandez-Abad, P.5
Ghosh, K.6
Nagi, A.7
-
6
-
-
67649660193
-
Quality by design approach to understand the process of nanosuspension preparation
-
Verma S, Lan Y, Gokhale R, Burgess D. 2009. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm 377:185-198.
-
(2009)
Int J Pharm
, vol.377
, pp. 185-198
-
-
Verma, S.1
Lan, Y.2
Gokhale, R.3
Burgess, D.4
-
7
-
-
68249125315
-
Quality-by-design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point
-
Wu H, Khan M. 2009. Quality-by-design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point. J Pharm Sci 98:2784-2798.
-
(2009)
J Pharm Sci
, vol.98
, pp. 2784-2798
-
-
Wu, H.1
Khan, M.2
-
8
-
-
67650122795
-
Quality by design: Optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design
-
Rafati H, Talebpour Z, Adlnasab L, Ebrahimi SN. 2009. Quality by design: Optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design. J Pharm Sci 98:2401-2411.
-
(2009)
J Pharm Sci
, vol.98
, pp. 2401-2411
-
-
Rafati, H.1
Talebpour, Z.2
Adlnasab, L.3
Ebrahimi, S.N.4
-
9
-
-
64549088926
-
Quality-by-design: An integrated multivariate approach for the component quantification in powder blends
-
Wu H, Tawakkul M, White M, Khan M. 2009. Quality-by-design: An integrated multivariate approach for the component quantification in powder blends. Int J Pharm 372:39-48.
-
(2009)
Int J Pharm
, vol.372
, pp. 39-48
-
-
Wu, H.1
Tawakkul, M.2
White, M.3
Khan, M.4
-
10
-
-
54949117110
-
Quality by design-Spray drying of insulin intended for inhalation
-
Maltesen MJ, Bjerregaard S, Hovgaard L, Havelund S, van Der Weert M. 2008. Quality by design-Spray drying of insulin intended for inhalation. Eur J Pharm Biopharm 70:828-838.
-
(2008)
Eur J Pharm Biopharm
, vol.70
, pp. 828-838
-
-
Maltesen, M.J.1
Bjerregaard, S.2
Hovgaard, L.3
Havelund, S.4
van Der, W.M.5
-
11
-
-
33846852628
-
Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function
-
Zidan A, Sammour O, Hammad M, Megrab NA, Habib MJ, Khan MA. 2007. Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. Int J Pharm 332:55-63.
-
(2007)
Int J Pharm
, vol.332
, pp. 55-63
-
-
Zidan, A.1
Sammour, O.2
Hammad, M.3
Megrab, N.A.4
Habib, M.J.5
Khan, M.A.6
-
12
-
-
77349122289
-
Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design
-
Rahman Z, Zidan AS, Habib MJ, Khan MA. 2010. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm 389:186-194.
-
(2010)
Int J Pharm
, vol.389
, pp. 186-194
-
-
Rahman, Z.1
Zidan, A.S.2
Habib, M.J.3
Khan, M.A.4
-
13
-
-
54949102425
-
Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester
-
Xie L, Wu H, Shen M, Augsburger LL, Lyon RC, Khan MA, Hussain AS, Hoag SW. 2008. Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester. J Pharm Sci 97:4485-4497.
-
(2008)
J Pharm Sci
, vol.97
, pp. 4485-4497
-
-
Xie, L.1
Wu, H.2
Shen, M.3
Augsburger, L.L.4
Lyon, R.C.5
Khan, M.A.6
Hussain, A.S.7
Hoag, S.W.8
-
14
-
-
65949099699
-
Development of a practical and efficient synthesis of CP-945598-01, a CB1 antagonist for the treatment of obesity
-
Ragan JA, Bourassa DE, Blunt J, Breen D, Busch FR, Cordi EM, Damon DB, Do N, Engtrakul A, Lynch D, McDermott RE, Mongillo JA, O'Sullivan MM, Rose PR, Vanderplas BC. 2009. Development of a practical and efficient synthesis of CP-945598-01, a CB1 antagonist for the treatment of obesity. Org Process Res Dev 13:186-197.
-
(2009)
Org Process Res Dev
, vol.13
, pp. 186-197
-
-
Ragan, J.A.1
Bourassa, D.E.2
Blunt, J.3
Breen, D.4
Busch, F.R.5
Cordi, E.M.6
Damon, D.B.7
Do, N.8
Engtrakul, A.9
Lynch, D.10
McDermott, R.E.11
Mongillo, J.A.12
O'Sullivan, M.M.13
Rose, P.R.14
Vanderplas, B.C.15
-
15
-
-
0347990428
-
Simulation of roller compaction using a laboratory scale compaction simulator
-
Zinchuk AV, Mullarney MP, Hancock BC. 2004. Simulation of roller compaction using a laboratory scale compaction simulator. Int J Pharm 269:403-415.
-
(2004)
Int J Pharm
, vol.269
, pp. 403-415
-
-
Zinchuk, A.V.1
Mullarney, M.P.2
Hancock, B.C.3
-
16
-
-
0027253630
-
Influence of microcrystalline cellulose source and batch variation on the tabletting behaviour and stability of prednisone formulations
-
Landin M, Martinez-Pacheco R, Gomez-Amoza JL, Souto C, Concheiro A, Rowe RC. 1993. Influence of microcrystalline cellulose source and batch variation on the tabletting behaviour and stability of prednisone formulations. Int J Pharm 91:143-149.
-
(1993)
Int J Pharm
, vol.91
, pp. 143-149
-
-
Landin, M.1
Martinez-Pacheco, R.2
Gomez-Amoza, J.L.3
Souto, C.4
Concheiro, A.5
Rowe, R.C.6
-
17
-
-
0033037592
-
Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets
-
Suzuki T, Nakagami H. 1999. Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets. Eur J Pharm Biopharm 47:225-230.
-
(1999)
Eur J Pharm Biopharm
, vol.47
, pp. 225-230
-
-
Suzuki, T.1
Nakagami, H.2
-
18
-
-
0037203723
-
Comparative evaluations of powder and mechanical properties of low crystallinity celluloses, microcrystalline cellulose, and powdered celluloses
-
Kothari SH, Kumar V, Banker GS. 2002. Comparative evaluations of powder and mechanical properties of low crystallinity celluloses, microcrystalline cellulose, and powdered celluloses. Int J Pharm 232:69-80.
-
(2002)
Int J Pharm
, vol.232
, pp. 69-80
-
-
Kothari, S.H.1
Kumar, V.2
Banker, G.S.3
-
19
-
-
0023113325
-
Studies on tableting properties of lactose. VII. The effect of variations in primary particle size and percentage of amporphous lactose in spray dried lactose products
-
Vromans H, Bolhuis GK, Lerk CF, van de Biggelaar H, Bosch H. 1987. Studies on tableting properties of lactose. VII. The effect of variations in primary particle size and percentage of amporphous lactose in spray dried lactose products. Int J Pharm 35:29-37.
-
(1987)
Int J Pharm
, vol.35
, pp. 29-37
-
-
Vromans, H.1
Bolhuis, G.K.2
Lerk, C.F.3
van de Biggelaar, H.4
Bosch, H.5
-
20
-
-
0028025198
-
Effect of moisture sorption on tabletting characteristics of spray dried (15% amorphous) lactose
-
Sebhatu T, Elamin AA, Ahlneck C. 1994. Effect of moisture sorption on tabletting characteristics of spray dried (15% amorphous) lactose. Pharm Res 11:1233-1238.
-
(1994)
Pharm Res
, vol.11
, pp. 1233-1238
-
-
Sebhatu, T.1
Elamin, A.A.2
Ahlneck, C.3
-
21
-
-
0021799190
-
Effect of molecular structure variation on the disintegrant action of sodium starch glycolate
-
Rudnic EM, Kanig JL, Rhodes CT. 1985. Effect of molecular structure variation on the disintegrant action of sodium starch glycolate. J Pharm Sci 74:647-650.
-
(1985)
J Pharm Sci
, vol.74
, pp. 647-650
-
-
Rudnic, E.M.1
Kanig, J.L.2
Rhodes, C.T.3
-
22
-
-
0022569179
-
On the similarity of sodium starch glycolate form different sources
-
Bolhius GK, van Kamp HV, Lerk CF. 1986. On the similarity of sodium starch glycolate form different sources. Drug Dev Ind Pharm 12:621-630.
-
(1986)
Drug Dev Ind Pharm
, vol.12
, pp. 621-630
-
-
Bolhius, G.K.1
van Kamp, H.V.2
Lerk, C.F.3
-
23
-
-
0028114630
-
Disintegration efficiency of sodium starch glycolates, prepared from different native starches
-
Bolhuis GK, Arends-Scholte AW, de Stuut GJ. 1994. Disintegration efficiency of sodium starch glycolates, prepared from different native starches. Eur J Pharm Biopharm 40:317-320.
-
(1994)
Eur J Pharm Biopharm
, vol.40
, pp. 317-320
-
-
Bolhuis, G.K.1
Arends-Scholte, A.W.2
de Stuut, G.J.3
-
24
-
-
0023212165
-
The effect of the variability in the physical and chemical properties of magnesium stearate on the properties of compressed tablets
-
Dansereau R, Peck GE. 1987. The effect of the variability in the physical and chemical properties of magnesium stearate on the properties of compressed tablets. Drug Dev Ind Pharm 13:975-999.
-
(1987)
Drug Dev Ind Pharm
, vol.13
, pp. 975-999
-
-
Dansereau, R.1
Peck, G.E.2
-
26
-
-
0029795306
-
Influence of the physicochemical variability of magnesium stearate on its lubricant properties: Possible solutions
-
Barra J, Somma R. 1996. Influence of the physicochemical variability of magnesium stearate on its lubricant properties: Possible solutions. Drug Dev Ind Pharm 22:1105-1120.
-
(1996)
Drug Dev Ind Pharm
, vol.22
, pp. 1105-1120
-
-
Barra, J.1
Somma, R.2
-
27
-
-
24744433720
-
Impact of solid-state properties on lubrication efficacy of magnesium stearate
-
Rao KP, Chawla G, Kaushal AM, Bansal AK. 2005. Impact of solid-state properties on lubrication efficacy of magnesium stearate. Pharm Dev Tech 10:423-437.
-
(2005)
Pharm Dev Tech
, vol.10
, pp. 423-437
-
-
Rao, K.P.1
Chawla, G.2
Kaushal, A.M.3
Bansal, A.K.4
-
28
-
-
34248993868
-
Understanding critical material properties for solid dosage form design
-
Hlinak AJ, Kuriyan K, Morris KR, Reklaitis GV, Basu PK. 2006. Understanding critical material properties for solid dosage form design. J Pharm Innov 1:13-17.
-
(2006)
J Pharm Innov
, vol.1
, pp. 13-17
-
-
Hlinak, A.J.1
Kuriyan, K.2
Morris, K.R.3
Reklaitis, G.V.4
Basu, P.K.5
-
29
-
-
34748877237
-
Lubrication of direct-compressible blends with magnesium stearate monohydrate and dihydrate
-
Okoye P, Wu SH. 2007. Lubrication of direct-compressible blends with magnesium stearate monohydrate and dihydrate. Pharm Technol 31:116-129.
-
(2007)
Pharm Technol
, vol.31
, pp. 116-129
-
-
Okoye, P.1
Wu, S.H.2
-
30
-
-
0032841721
-
Rheological characterization of pharmaceutical powders using tap testing, shear cell and mercury porosimeter
-
Guerin E, Tchoreloff P, Leclerc B, Tanguy D, Deleuil M, Couarraze G. 1999. Rheological characterization of pharmaceutical powders using tap testing, shear cell and mercury porosimeter. Int J Pharm 189:91-103.
-
(1999)
Int J Pharm
, vol.189
, pp. 91-103
-
-
Guerin, E.1
Tchoreloff, P.2
Leclerc, B.3
Tanguy, D.4
Deleuil, M.5
Couarraze, G.6
-
31
-
-
0033782996
-
Powder and capsule filling properties of lubricated granulated cellulose powder
-
Podczeck F, Newton JM. 2000. Powder and capsule filling properties of lubricated granulated cellulose powder. Eur J Pharm Biopharm 50:373-377.
-
(2000)
Eur J Pharm Biopharm
, vol.50
, pp. 373-377
-
-
Podczeck, F.1
Newton, J.M.2
-
32
-
-
74049129308
-
Improving powder flow properties of a cohesive lactose monohydrate powder by intensive mechanical dry coating
-
Zhou Q, Armstrong B, Larson I, Stewart PJ, Morton DAV. 2010. Improving powder flow properties of a cohesive lactose monohydrate powder by intensive mechanical dry coating. J Pharm Sci 99:969-981.
-
(2010)
J Pharm Sci
, vol.99
, pp. 969-981
-
-
Zhou, Q.1
Armstrong, B.2
Larson, I.3
Stewart, P.J.4
Morton, D.A.V.5
-
33
-
-
71049181446
-
Practical methods for improving flow properties of active pharmaceutical ingredients
-
Pingali KC, Saranteas K, Foroughi R, Muzzio FJ. 2009. Practical methods for improving flow properties of active pharmaceutical ingredients. Drug Dev Ind Pharm 35:1460-1469.
-
(2009)
Drug Dev Ind Pharm
, vol.35
, pp. 1460-1469
-
-
Pingali, K.C.1
Saranteas, K.2
Foroughi, R.3
Muzzio, F.J.4
-
34
-
-
85031240446
-
-
US Pharmacopeia XXXII. Rockville, Maryland: US Pharmacopeial Convention
-
US Pharmacopeia XXXII. 2008. General chapter 1216. Rockville, Maryland: US Pharmacopeial Convention, pp 725.
-
(2008)
General chapter 1216
, pp. 725
-
-
-
35
-
-
51449099179
-
Effect of particle size on compaction of materials with different deformation mechanisms with and without lubricants
-
Almaya A, Aburub A. 2008. Effect of particle size on compaction of materials with different deformation mechanisms with and without lubricants. AAPS PharmSciTech 9:414-418.
-
(2008)
AAPS PharmSciTech
, vol.9
, pp. 414-418
-
-
Almaya, A.1
Aburub, A.2
-
36
-
-
33645224298
-
Reduced tabletability of roller compacted granules as a result of granule size enlargement
-
Sun C, Himmelspach MW. 2006. Reduced tabletability of roller compacted granules as a result of granule size enlargement. J Pharm Sci 95:200-206.
-
(2006)
J Pharm Sci
, vol.95
, pp. 200-206
-
-
Sun, C.1
Himmelspach, M.W.2
-
37
-
-
0035157917
-
Fine-particle ethylcellulose as a tablet binder in direct compression, immediate-release tablets
-
Desai RP, Neau SH, Pather SI, Johnston TP. 2001. Fine-particle ethylcellulose as a tablet binder in direct compression, immediate-release tablets. Drug Dev Ind Pharm 27:633-641.
-
(2001)
Drug Dev Ind Pharm
, vol.27
, pp. 633-641
-
-
Desai, R.P.1
Neau, S.H.2
Pather, S.I.3
Johnston, T.P.4
|