-
1
-
-
67650264812
-
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1A(R2): Stability Testing of New Drug Substances and Products, Step 4, 6 February 2003, Available at: http://www.ich.org/.
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1A(R2): Stability Testing of New Drug Substances and Products, Step 4, 6 February 2003, Available at: http://www.ich.org/.
-
-
-
-
2
-
-
67650231065
-
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1E: Evaluation for stability data, Step 4, 6 February 2003, Available at: http://www.ich.org/.
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1E: Evaluation for stability data, Step 4, 6 February 2003, Available at: http://www.ich.org/.
-
-
-
-
3
-
-
67650240567
-
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3A(R2): Impurities in New Drug Substances, Step 4, 25 October 2006, Available at: http://www.ich.org/.
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3A(R2): Impurities in New Drug Substances, Step 4, 25 October 2006, Available at: http://www.ich.org/.
-
-
-
-
4
-
-
67650249668
-
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3B(R2): Impurities in New Drug Products, Step 4, 2 June 2006, Available at: http://www.ich.org/.
-
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3B(R2): Impurities in New Drug Products, Step 4, 2 June 2006, Available at: http://www.ich.org/.
-
-
-
-
5
-
-
33846785326
-
-
Alsante K.M., Ando A., Brown R., Ensing J., Hatajik T.D., Kong W., and Tsuda Y. 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
-
8
-
-
0038669070
-
-
Sims J.L., Carreira J.A., Carrier D.J., Crabtree S.R., Easton L., Hancock S.A., and Simcox C.E. Pharm. Dev. Technol. 8 (2003) 119-126
-
(2003)
Pharm. Dev. Technol.
, vol.8
, pp. 119-126
-
-
Sims, J.L.1
Carreira, J.A.2
Carrier, D.J.3
Crabtree, S.R.4
Easton, L.5
Hancock, S.A.6
Simcox, C.E.7
-
10
-
-
67650273781
-
-
Banker G.S., and Rhodes C.T. (Eds), Informa Healthcare, USA
-
Guillory J.K., and Poust R.I. In: Banker G.S., and Rhodes C.T. (Eds). Modern Pharmaceutics. fourth ed. (2002), Informa Healthcare, USA 146-173
-
(2002)
Modern Pharmaceutics. fourth ed.
, pp. 146-173
-
-
Guillory, J.K.1
Poust, R.I.2
-
12
-
-
0036395858
-
-
Waterman K.C., Adami R.C., Alsante K.M., Hong J., Landis M.S., Lombardo F., and Roberts C.J. Pharm. Dev. Technol. 7 (2002) 1-32
-
(2002)
Pharm. Dev. Technol.
, vol.7
, pp. 1-32
-
-
Waterman, K.C.1
Adami, R.C.2
Alsante, K.M.3
Hong, J.4
Landis, M.S.5
Lombardo, F.6
Roberts, C.J.7
-
13
-
-
33745903417
-
-
Nelson E.D., Harmon P.A., Szymanik R.C., Teresk M.G., Li L., Seburg R.A., and Reed R.A. J. Pharm. Sci. 95 (2006) 1527-1539
-
(2006)
J. Pharm. Sci.
, vol.95
, pp. 1527-1539
-
-
Nelson, E.D.1
Harmon, P.A.2
Szymanik, R.C.3
Teresk, M.G.4
Li, L.5
Seburg, R.A.6
Reed, R.A.7
-
14
-
-
33748929319
-
-
Harmon P.A., Kosuda K., Nelson E., Mowery M., and Reed R.A. J. Pharm. Sci. 95 (2006) 2014-2028
-
(2006)
J. Pharm. Sci.
, vol.95
, pp. 2014-2028
-
-
Harmon, P.A.1
Kosuda, K.2
Nelson, E.3
Mowery, M.4
Reed, R.A.5
-
18
-
-
62849098503
-
-
Nelson E.D., Thompson G.M., Yao Y., Flanagan H.M., and Harmon P.A. J. Pharm. Sci. 98 (2009) 959-969
-
(2009)
J. Pharm. Sci.
, vol.98
, pp. 959-969
-
-
Nelson, E.D.1
Thompson, G.M.2
Yao, Y.3
Flanagan, H.M.4
Harmon, P.A.5
-
21
-
-
67650240566
-
-
Smith R.J., and Webb M.L. (Eds), Blackwell Publishing, Oxford
-
Hammond J., and Jones I. In: Smith R.J., and Webb M.L. (Eds). Analysis of Drug Impurities (2007), Blackwell Publishing, Oxford 156-214
-
(2007)
Analysis of Drug Impurities
, pp. 156-214
-
-
Hammond, J.1
Jones, I.2
-
25
-
-
0000549006
-
-
Gorog S. (Ed), Elsevier, Amsterdam
-
Wilson I.D., Griffiths L., Lindon J.C., and Nicholson J.K. In: Gorog S. (Ed). Identification and Determination of Impurities in Drugs (2000), Elsevier, Amsterdam 299-322
-
(2000)
Identification and Determination of Impurities in Drugs
, pp. 299-322
-
-
Wilson, I.D.1
Griffiths, L.2
Lindon, J.C.3
Nicholson, J.K.4
-
27
-
-
0346910080
-
-
Albert K. (Ed), Wiley, Chichester
-
Lindon J.C., Nicholson J.K., and Wilson I.D. In: Albert K. (Ed). On-line LC-NMR and Related Techniques (2002), Wiley, Chichester 45-88
-
(2002)
On-line LC-NMR and Related Techniques
, pp. 45-88
-
-
Lindon, J.C.1
Nicholson, J.K.2
Wilson, I.D.3
-
28
-
-
33746382906
-
-
Baranczewski P., Kautiainen A., Kautiainen A., Sandin P., and Edlund P.O. Pharmacol. Rep. 58 (2006) 341-352
-
(2006)
Pharmacol. Rep.
, vol.58
, pp. 341-352
-
-
Baranczewski, P.1
Kautiainen, A.2
Kautiainen, A.3
Sandin, P.4
Edlund, P.O.5
-
33
-
-
0036127307
-
-
Dalvie D.K., Kalgutkar A.S., Khojasteh-Bakht S.C., Obach R.S., and O'Donnell J.P. Chem. Res. Toxicol. 15 (2002) 269-299
-
(2002)
Chem. Res. Toxicol.
, vol.15
, pp. 269-299
-
-
Dalvie, D.K.1
Kalgutkar, A.S.2
Khojasteh-Bakht, S.C.3
Obach, R.S.4
O'Donnell, J.P.5
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