-
1
-
-
33846785326
-
The role of degradant profiling in active pharmaceutical ingredients and drug products
-
Alsante, K.M., Ando, A., Brown, R., Ensing, J., Hatajik, T.D., Kong, W., Tsuda, Y., The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv. Drug Deliv. Rev. 59 (2007), 29–37.
-
(2007)
Adv. Drug Deliv. Rev.
, vol.59
, pp. 29-37
-
-
Alsante, K.M.1
Ando, A.2
Brown, R.3
Ensing, J.4
Hatajik, T.D.5
Kong, W.6
Tsuda, Y.7
-
2
-
-
0037097780
-
Development of validated stability-indicating assay methods – critical review, J. Pharmaceut
-
Bakshi, M., Singh, S., Development of validated stability-indicating assay methods – critical review, J. Pharmaceut. Biomed. Anal. 28 (2002), 1011–1040.
-
(2002)
Biomed. Anal.
, vol.28
, pp. 1011-1040
-
-
Bakshi, M.1
Singh, S.2
-
3
-
-
85006374679
-
-
ICH, 2005. Validation of analytical procedures: text and methodology, Q2 (R1). In: International Conference of Harmonization of Technical Requirements for Registration Pharmaceuticals for Human Use. IFPMA, Geneva. <>. Visited On 12th June 2011.
-
ICH, 2005. Validation of analytical procedures: text and methodology, Q2 (R1). In: International Conference of Harmonization of Technical Requirements for Registration Pharmaceuticals for Human Use. IFPMA, Geneva. < http://www.ich.org>. Visited On 12th June 2011.
-
-
-
-
4
-
-
13444273611
-
Toward a generic approach for stress testing of drug substances and drug products
-
Klick, S.P., Muijselaar, T., Eichinger, C., Korn, T., Gerding, A., Debert, C., Griend, C., Beld, G., Somsen, G., Jong, J., Toward a generic approach for stress testing of drug substances and drug products. Pharm. Technol., 2005, 48–66.
-
(2005)
Pharm. Technol.
, pp. 48-66
-
-
Klick, S.P.1
Muijselaar, T.2
Eichinger, C.3
Korn, T.4
Gerding, A.5
Debert, C.6
Griend, C.7
Beld, G.8
Somsen, G.9
Jong, J.10
-
5
-
-
70349303615
-
Experimental design in chemistry: a tutorial
-
Leardi, R., Experimental design in chemistry: a tutorial. Anal. Chim. Acta 652 (2009), 161–172.
-
(2009)
Anal. Chim. Acta
, vol.652
, pp. 161-172
-
-
Leardi, R.1
-
6
-
-
0032563561
-
Experimental design and optimization
-
Lundstedt, T., Seifert, E., Abramo, L., Thelin, B., Nystrom, J., Pettersen, J., Bergman, R., Experimental design and optimization. Chemom. Intell. Lab. Syst. 42 (1998), 3–40.
-
(1998)
Chemom. Intell. Lab. Syst.
, vol.42
, pp. 3-40
-
-
Lundstedt, T.1
Seifert, E.2
Abramo, L.3
Thelin, B.4
Nystrom, J.5
Pettersen, J.6
Bergman, R.7
-
7
-
-
0000150028
-
Practical exploratory experimental designs
-
Morgan, E., Burton, K.W., Church, P.A., Practical exploratory experimental designs. Chemom. Intell. Lab. Syst. 5 (1989), 283–302.
-
(1989)
Chemom. Intell. Lab. Syst.
, vol.5
, pp. 283-302
-
-
Morgan, E.1
Burton, K.W.2
Church, P.A.3
-
8
-
-
0036178655
-
Available guidance and best practices for conducting forced degradation studies
-
Reynolds, D.W., Facchine, K.L., Mullaney, J.F., Alsante, K.M., Hatajik, T.D., Motto, M.G., Available guidance and best practices for conducting forced degradation studies. Pharm. Technol., 2000, 48–56.
-
(2000)
Pharm. Technol.
, pp. 48-56
-
-
Reynolds, D.W.1
Facchine, K.L.2
Mullaney, J.F.3
Alsante, K.M.4
Hatajik, T.D.5
Motto, M.G.6
-
9
-
-
0002990443
-
Guidance on conduct of stress testing to determine inherent stability of drugs
-
Pharm. Technol. 1–14.
-
Singh, S., Bakshi, M., 2000. Guidance on conduct of stress testing to determine inherent stability of drugs. Pharm. Technol. 1–14.
-
(2000)
-
-
Singh, S.1
Bakshi, M.2
-
10
-
-
4644301871
-
In vitro antifungal activity of luliconazole (NND-502), a novel imidazole antifungal agent
-
Uchida, K., Nishiyama, Y., Yamaguchi, H., In vitro antifungal activity of luliconazole (NND-502), a novel imidazole antifungal agent. J. Infect. Chemother. 10 (2004), 216–219.
-
(2004)
J. Infect. Chemother.
, vol.10
, pp. 216-219
-
-
Uchida, K.1
Nishiyama, Y.2
Yamaguchi, H.3
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