REFERENCES
- Doribax , T. M. (Doripenem for Injection) for Intravenous Infusion. http://www.doribax.com/doribax/interactive_pi.html
- Castanheira , M. ; Jones , R. N. ; Livermore , D. M. Antimicrobial activities of doripenem and other carbapenems against Pseudomonas aeruginosa, other nonfermentative bacilli, and Aeromonas spp. Diagn. Microbiol. Infect. Dis. 2009 , 63 , 426 – 433 .
- Huynh , H. K. ; Biedenbach , D. J. ; Jones , R. N. Delayed resistance selection for doripenem when passaging Pseudomonas aeruginosa isolates with doripenem plus an aminoglycoside . Diagn. Microbiol. Infect. Dis. 2006 , 55 , 241 – 243 .
- Jones , R. N. ; Sader , H. S. ; Fritsche , T. H. Comparative activity of doripenem and three other carbapenems tested against Gram-negative bacilli with various β-lactamase resistance mechanisms . Diagn. Microbiol. Infect. Dis. 2004 , 52 , 71 .
- Wexler , H. M. ; Engel , A. E. ; Glass , D. ; Li , C. In Vitro Activities of Doripenem and Comparator Agents against 364 Anaerobic Clinical Isolates . Antimicrob. Agents Chemother. 2005 , 49 , 4413 .
- Sutherland , Ch. ; Nicolau , D. P. Development of an HPLC method for the determination of doripenem in human and mouse serum . J. Chromatogr. B 2007 , 853 , 123 – 126 .
- Ikeda , K. ; Ikawa , K. ; Morikawa , N. ; Kameda , K. ; Urakawa , N. ; Ohge , H. ; Sueda , Quantification of doripenem in human plasma and peritoneal fluid by high-performance liquid chromatography with ultraviolet detection . J. Chromatogr. B . 2008 , 867 , 20 – 25 .
- Psathas , P. A. ; Kuzmission , A. ; Ikeda , K. ; Yasuo , S. Stability of doripenem in vitro in representative infusion solutions and infusion bags . Clin. Ther. 2008 , 30 , 2075 .
- Cielecka-Piontek , J. ; Jelinska , A. ; Zajac , M. ; Zukowska , M. 5th German-Polish Symposium “New Challenges for Pharmaceutical Sciences”, Poznan, May 15–16, 2010 . Spectrochim. Acta Part A 2009 , 77 , 554 – 557 .
- Michalska , K. ; Pajchel , G. ; Tyski , S. Determination of doripenem and related substances in medicinal product using capillary electrophoresis . J. Sep. Sci. 2011 , 34 , 475 – 482 .
- Cielecka-Piontek , J. ; Jelinska , A. The UV-derivative spectrophotometry for the determination of doripenem in the presence of its degradation products . Spectrochim. Acta Part A 2010 , 77 , 554 – 557 .
- Clarke , G. S. The validation of analytical methods for drug substances and drug products in UK pharmaceutical laboratories . J. Pharm. Biomed. Anal. 1994 , 12 , 643 – 652 . doi: 10.1016/0731-7085(93)E0018-I
- FDA. Food and Drug Administration, 1994, Guidance for Industry: Analytical Procedures and Methods Validation. (Draft Guidance).
- FDA. Food and Drug Administration, Center of Drug Evolution and Research, 1994, Reviewer Guidance, Validation of Chromatographic Methods .
- ICH. International Conference on Harmonization, October 1994, Text on Validation of Analytical Procedures Q2A .
- ICH. International Conference on Harmonization November 1996, Validation of Analytical Procedures Methodology (Q2B) .
- ICH. International Conference on Harmonization October 1994, Harmonized Tripartite Guideline Prepared with in the Third International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for the Human Use: Text on Validation of Analytical Procedures .