References
- Veys , E. M. 1991 . 20 years' experience with ketoprofen . Scand. J. Rheumatol. , 90 : 3 – 44 .
- Anacardio , R. , Perilli , O. , Bartolini , S. , Gentile , M. M. , Mazzeo , P. and Carlucci , G. 2003 . Physicochemical compatibility between ketoprofen lysine salt injections (Atrosilene) and pharmaceutical products frequently used for combined therapy by intravenous administration . J. Pharm. Biomed. Anal. , 32 : 1235 – 1241 .
- 1987 . Guidelines on General Principles of Process Validation . Food and Drug Administration, http:\\www.fda.gov/cdrh/ode/425.pdf
- Note for Guidance on Validation of Analytical Methods: Definitions and Terminology . Step 5, CPMP/ICH/381/95, (CPMP Adopted November 1994)
- 2003 . “ The United States Pharmacopeia, 26th Rev, and the National Formulary ” . In , 21st edn. 2439 – 2442 . Rockville : United States Pharmacopeia Convention, Inc . USP 26/NF21
- Note for Guidance on Validation of Analytical Procedures: Methodology . ICH Topic Q2B Validation of Analytical Procedures: Methodology-Step 4 CPMP/ICH/281/95, (CPMP Adopted December 1996)
- 1996 . International Conference on Harmonization, ICH‐Q2B . November 1996 .
- 1997 . Validation of Analytical Methods . The third International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals in Human Use (ICH) . 1997 , Yokohama, Japan. International Conference on Harmonisation, Topic Q2B
- Miller , J. C. and Miller , J. N. 1984 . Statistics for Analytical Chemistry 90 – 98 . New York : Wiley . Ch. 4
- Vander Heyden , Y. , Nijhuis , A. , Smeyers‐Verbeke , J. , Vandeginste , B. G.M. and Massart , D. L. 2001 . Guidance for robustness‐ruggedness tests in method validation . J. Pharm. Biomed. Anal. , 24 : 723 – 753 .