1 |
LG Life Science DMF Number 14524; FDA: Rockville, MD, USA, 1999
|
2 |
Pathare, D. B.; Jadhav, A. S. J. Pharm. Biomed. Anal. 2006, 41, 1152
DOI
ScienceOn
|
3 |
Guideline for Industry, Q1A Stability Testing of New Drug Substances and Products, ICH, Federal Register; FDA: Rockville, MD, 1996
|
4 |
Reviewer Guidance, Validation of Chromatographic Methods; Center for Drug Evaluation and Research, FDA: Rockville, MD, 1994
|
5 |
Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH, Federal Register; FDA: Rockville, MD, 2005
|
6 |
Shirota, O.; Ohtsu, Y.; Nakata, O. J. Chromatogr. Sci. 1990, 28, 553
DOI
|
7 |
Hong, C. Y. IL. FARMACO 2001, 56, 41
DOI
ScienceOn
|
8 |
Kele, M.; Cuiochon, G. J. Chromatogr. 2000, 869, 181
DOI
ScienceOn
|