-
1
-
-
0003548169
-
-
US Food and Drug Administration, (FDA), Office of Regulatory Affairs, Washington, DC, available at: (20/05/2008)
-
Guide to Inspections Validation of Cleaning Processes, US Food and Drug Administration, (FDA), Office of Regulatory Affairs, Washington, DC, pp 1-6; available at: http://www.fda.gov/ora/inspect ref/igs/valid.html (20/05/2008)
-
Guide to Inspections Validation of Cleaning Processes
, pp. 1-6
-
-
-
3
-
-
0028097453
-
-
J.S. Grundy, R. Kherani, and R.T. Foster, J. Pharm. Biomed. Anal., 12, 1529 (1994)
-
(1994)
J. Pharm. Biomed. Anal.
, vol.12
, pp. 1529
-
-
Grundy, J.S.1
Kherani, R.2
Foster, R.T.3
-
4
-
-
0025761915
-
-
N. Beaulieu, N.M. Curran, S.J. Graham, R.W. Sears, E.G. Lovering, J. Liq. Chromatogr., 14, 1173 (1991)
-
(1991)
J. Liq. Chromatogr.
, vol.14
, pp. 1173
-
-
Beaulieu, N.1
Curran, N.M.2
Graham, S.J.3
Sears, R.W.4
Lovering, E.G.5
-
5
-
-
70450250632
-
-
L. Bing, H. Defu, and L. Fei, Yaowu Fenxi Zazhi, 24, 485 (2004)
-
(2004)
Yaowu Fenxi Zazhi
, vol.24
, pp. 485
-
-
Bing, L.1
Defu, H.2
Fei, L.3
-
6
-
-
85153237747
-
-
C. Jianhui, D. Shuhai, and W. Hongshui, Zhongguo Yiyao Gongye Zazhy, 35, 39 (2004)
-
(2004)
Zhongguo Yiyao Gongye Zazhy
, vol.35
, pp. 39
-
-
Jianhui, C.1
Shuhai, D.2
Hongshui, W.3
-
7
-
-
85153215077
-
-
W. Zhongyan, T. Xing, H. Jinggang, P. Chunming, and W. Xiaojun, Shenyang Yaoke Daxue Xuebao, 19, 38 (2002)
-
(2002)
Shenyang Yaoke Daxue Xuebao
, vol.19
, pp. 38
-
-
Zhongyan, W.1
Xing, T.2
Jinggang, H.3
Chunming, P.4
Xiaojun, W.5
-
8
-
-
0032545350
-
-
P.Y. Patel, P. Suvarna, I.C. Bhoir, and M. Sundaresa, J. Chromatogr. A, 828, 283- 286 (1998)
-
(1998)
J. Chromatogr. A
, vol.828
, pp. 283-286
-
-
Patel, P.Y.1
Suvarna, P.2
Bhoir, I.C.3
Sundaresa, M.4
-
12
-
-
0011066450
-
-
G.R. Rao, S. Raghuveer, and C.M.R. Srivastava, Indian Drugs, 22, 435-435 (1985)
-
(1985)
Indian Drugs
, vol.22
, pp. 435-435
-
-
Rao, G.R.1
Raghuveer, S.2
Srivastava, C.M.R.3
-
13
-
-
0033954047
-
-
H.S. Abou-Auda, T.A. Najjar, K. Al-Khamis, B.M. Al-Hadiya, N.M. Ghilzai, and N.F. Al-Fawzan, J. Pharm. Biomed. Anal., 22, 241-249 (2000)
-
(2000)
J. Pharm. Biomed. Anal.
, vol.22
, pp. 241-249
-
-
Abou-Auda, H.S.1
Najjar, T.A.2
Al-Khamis, K.3
Al-Hadiya, B.M.4
Ghilzai, N.M.5
Al-Fawzan, N.F.6
-
14
-
-
31344474817
-
-
K. Javidnia, R. Miri, and A. Jamalian, J. Pharm. Biomed. Anal., 40, 438-442 (2006)
-
(2006)
J. Pharm. Biomed. Anal.
, vol.40
, pp. 438-442
-
-
Javidnia, K.1
Miri, R.2
Jamalian, A.3
-
16
-
-
34447625260
-
-
Z. Li, M. Zhong, X. Shi, and Z. Li, Zhongguo Linchuang Yaoxue Zazhi, 14, 115- 117 (2005)
-
(2005)
Zhongguo Linchuang Yaoxue Zazhi
, vol.14
, pp. 115-117
-
-
Li, Z.1
Zhong, M.2
Shi, X.3
Li, Z.4
-
17
-
-
0033753962
-
-
M. Zaater, E. Hasan, and N. Najib, Polish J. Pharmacol., 52, 307-312 (2000)
-
(2000)
Polish J. Pharmacol.
, vol.52
, pp. 307-312
-
-
Zaater, M.1
Hasan, E.2
Najib, N.3
-
18
-
-
70450256247
-
-
Q. Ge, H. Wang, Z. Zhou, M. Fu, and G. Liu, Zhongguo Yiyao Gongye Zazhi, 31, 31-33 (2000)
-
(2000)
Zhongguo Yiyao Gongye Zazhi
, vol.31
, pp. 31-33
-
-
Ge, Q.1
Wang, H.2
Zhou, Z.3
Fu, M.4
Liu, G.5
-
20
-
-
0029965684
-
-
A. Goldnik, M. Gajewska, D. Marszalek, and M. Przyzycki, Acta Pol. Pharm., 53, 7-8 (1996)
-
(1996)
Acta Pol. Pharm.
, vol.53
, pp. 7-8
-
-
Goldnik, A.1
Gajewska, M.2
Marszalek, D.3
Przyzycki, M.4
-
21
-
-
0027489595
-
-
Y.M. El-Sayed, E.M. Niazy, and S.H. Khidr, J. Clin. Pharm. Ther., 18, 325-330 (1993)
-
(1993)
J. Clin. Pharm. Ther.
, vol.18
, pp. 325-330
-
-
El-Sayed, Y.M.1
Niazy, E.M.2
Khidr, S.H.3
-
22
-
-
33746029686
-
-
M.V. Vertzoni, C. Reppas, and H.A. Archontaki, Anal. Chim. Acta, 573, 298-304 (2006)
-
(2006)
Anal. Chim. Acta
, vol.573
, pp. 298-304
-
-
Vertzoni, M.V.1
Reppas, C.2
Archontaki, H.A.3
-
23
-
-
0028218577
-
-
J.S. Grundy, R. Kherani, and R. Foster, J. Chromatogr. B, 654, 146-151 (1994)
-
(1994)
J. Chromatogr. B
, vol.654
, pp. 146-151
-
-
Grundy, J.S.1
Kherani, R.2
Foster, R.3
-
24
-
-
34447645666
-
-
Y. Guo, J. Dai, G. Qian, N. Guo, Z. Ma, and X. Guo, Int. J. Pharm., 341, 91-96 (2007)
-
(2007)
Int. J. Pharm.
, vol.341
, pp. 91-96
-
-
Guo, Y.1
Dai, J.2
Qian, G.3
Guo, N.4
Ma, Z.5
Guo, X.6
-
25
-
-
0033968307
-
-
M. Yritia, P. Parra, E. Iglesias, and J.M. Barbanoj, J. Chromatogr. A, 870, 115-119 (2000)
-
(2000)
J. Chromatogr. A
, vol.870
, pp. 115-119
-
-
Yritia, M.1
Parra, P.2
Iglesias, E.3
Barbanoj, J.M.4
-
28
-
-
34249704588
-
-
X.D. Wang, J.L. Li, Y. Lu, X. Chen, M. Huang, B. Chowbay, and S. Zhou, J. Chromatogr. B, 852, 534-544 (2007)
-
(2007)
, vol.852
, pp. 534-544
-
-
Wang, X.D.1
Li, J.L.2
Lu, Y.3
Chen, X.4
Huang, M.5
Chowbay, B.6
Zhou, S.7
-
29
-
-
33745817027
-
-
D. Zendelovska, S. Simeska, O. Sibinovska, E. Kostova, K. Miloševska, K. Jakovski, E. Jovanovska, I. Kikerkov, J. Trojačanec, and D. Zafirov, J. Chromatogr. B, 839, 85-88 (2006)
-
(2006)
J. Chromatogr. B
, vol.839
, pp. 85-88
-
-
Zendelovska, D.1
Simeska, S.2
Sibinovska, O.3
Kostova, E.4
Miloševska, K.5
Jakovski, K.6
Jovanovska, E.7
Kikerkov, I.8
Trojačanec, J.9
Zafirov, D.10
-
30
-
-
0009530961
-
-
D. Xia, B. Liu, M. Yan, E. Sui, and L. Chen, Shenyang Yaoxueyuan Xuebao, 11, 130-132 (1994)
-
(1994)
Shenyang Yaoxueyuan Xuebao
, vol.11
, pp. 130-132
-
-
Xia, D.1
Liu, B.2
Yan, M.3
Sui, E.4
Chen, L.5
-
33
-
-
0038064325
-
-
R. Klinkerberg, B. Streel, and A. Ceccato, J. Pharm. Biomed. Anal., 32, 345-352 (2003)
-
(2003)
J. Pharm. Biomed. Anal.
, vol.32
, pp. 345-352
-
-
Klinkerberg, R.1
Streel, B.2
Ceccato, A.3
-
34
-
-
33847135774
-
-
T.T. Fazio, A.K. Singh, E.R.M. Kedor-Hackmann, and M.I.R.M. Santoro, J. Pharm. Biomed. Anal., 43, 1495-1498 (2007)
-
(2007)
J. Pharm. Biomed. Anal.
, vol.43
, pp. 1495-1498
-
-
Fazio, T.T.1
Singh, A.K.2
Kedor-Hackmann, E.R.M.3
Santoro, M.I.R.M.4
-
35
-
-
0033120887
-
-
T. Mirza, M.J. Lunn, F.J. Keeley, R.C. George, and J.R. Bodenmiller, J. Pharm. Biomed. Anal., 19, 747-756 (1999)
-
(1999)
J. Pharm. Biomed. Anal.
, vol.19
, pp. 747-756
-
-
Mirza, T.1
Lunn, M.J.2
Keeley, F.J.3
George, R.C.4
Bodenmiller, J.R.5
-
36
-
-
0348110619
-
-
M.J. Nozal, J.L. Bernal, J.J. Jimenez, M.T. Martin, and F.J. Diez, J. Chromatogr. A, 1024, 115-122 (2004)
-
(2004)
J. Chromatogr. A
, vol.1024
, pp. 115-122
-
-
Nozal, M.J.1
Bernal, J.L.2
Jimenez, J.J.3
Martin, M.T.4
Diez, F.J.5
-
37
-
-
0037026372
-
-
M.J. Nozal, J.L. Bernal, L. Toribio, M.T. Martin, and F.J. Diez, J. Pharm. Biomed. Anal., 30, 285-291 (2002)
-
(2002)
J. Pharm. Biomed. Anal.
, vol.30
, pp. 285-291
-
-
Nozal, M.J.1
Bernal, J.L.2
Toribio, L.3
Martin, M.T.4
Diez, F.J.5
-
38
-
-
0035369832
-
-
M.J. Nozal, J.L. Bernal, L. Toribio, M.T. Martin, and F.J. Diez, J. Chromatogr. A, 919, 87-93
-
J. Chromatogr. A
, vol.919
, pp. 87-93
-
-
Nozal, M.J.1
Bernal, J.L.2
Toribio, L.3
Martin, M.T.4
Diez, F.J.5
-
39
-
-
0033978105
-
-
M.J. Nozal, J.L. Bernal, L. Toribio, J.J. Jimenez, and M.T. Martin, J. Chromatogr. A, 870, 69-75 (2000)
-
(2000)
J. Chromatogr. A
, vol.870
, pp. 69-75
-
-
Nozal, M.J.1
Bernal, J.L.2
Toribio, L.3
Jimenez, J.J.4
Martin, M.T.5
-
40
-
-
0034664090
-
-
J. Lambropoulos, G.A. Spanos, and N.V. Lazaridis, J. Pharm. Biomed. Anal., 23, 421-428 (2000)
-
(2000)
J. Pharm. Biomed. Anal.
, vol.23
, pp. 421-428
-
-
Lambropoulos, J.1
Spanos, G.A.2
Lazaridis, N.V.3
-
41
-
-
14644422155
-
-
M.B. Boca, Z. Apostolides, and E. Pretorius, J. Pharm. Biomed. Anal., 37, 461-468 (2005)
-
(2005)
J. Pharm. Biomed. Anal.
, vol.37
, pp. 461-468
-
-
Boca, M.B.1
Apostolides, Z.2
Pretorius, E.3
-
42
-
-
14644408710
-
-
P. Sajonz, T.K. Natishan, Y. Wu, N.T. McGachy, and D. DeTora, J. Liq. Chromatogr. Related Technol., 28, 713-725 (2005)
-
(2005)
J. Liq. Chromatogr. Related Technol.
, vol.28
, pp. 713-725
-
-
Sajonz, P.1
Natishan, T.K.2
Wu, Y.3
McGachy, N.T.4
DeTora, D.5
-
44
-
-
85153240812
-
-
Validation of Analytical Procedures: Text and Methodology, available at: (20/05/2008)
-
International Conference on Harmonization Q2 (R1): Validation of Analytical Procedures: Text and Methodology, available at: http://www.ich.org/ cache/ compo/276-254-1.html (20/05/2008)
-
International Conference on Harmonization Q2 (R1)
-
-
|