Determination of tigecycline in human skin using a novel validated LC-MS/MS method

Bioanalysis

Volumn 2, Issue 1, 2010, Pages 81-94

  Ji Ji, Allena ^a   Saunders, James Patrick ^a   Amorusi, Peter ^a   Stein, Gary ^b   Wadgaonkar, Nandan Dilip ^a   O'leary, Kenneth Patrick ^a   Leal, Mauricio ^a   Fluhler, Eric Norbert ^a  

^a WYETH RESEARCH   (United States)

^b MICHIGAN STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACID; METHANOL; SOLVENT; STABILIZING AGENT; TIGECYCLINE; ANTIINFECTIVE AGENT; DRUG DERIVATIVE; MINOCYCLINE;

ACCURACY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CENTRIFUGATION; CONTROLLED STUDY; DRUG TUMOR LEVEL; EXTRACTION; FILTRATION; HUMAN; HUMAN TISSUE; LIQUID CHROMATOGRAPHY; LIVER; LOADING DRUG DOSE; MASS SPECTROMETRY; NONHUMAN; RAT; SAMPLE SIZE; SKIN; SUSPENSION; TISSUE HOMOGENATE; VALIDATION STUDY; VOLUNTEER; ANIMAL; CHEMISTRY; METHODOLOGY; SPRAGUE DAWLEY RAT; TANDEM MASS SPECTROMETRY;

ANIMALS; ANTI-BACTERIAL AGENTS; CHROMATOGRAPHY, LIQUID; HUMANS; LIVER; MINOCYCLINE; RATS; RATS, SPRAGUE-DAWLEY; SKIN; TANDEM MASS SPECTROMETRY;

EID: 79953301838     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.159     Document Type: Article

References (18)

1. Grolman DC. Therapeutic applications of tigecycline in the management of complicated skin and skin structure infections. Int. J. Infect. Dis. 11(Suppl. 1), S7-S15 (2007) (Pubitemid 46977799)
2. Ramesh MK, Sastry RA, Rekha A, et al. Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections. Presented at: The 10th Western Pacific Congress on Chemotherapy and Infectious Diseases. Fukuoka, Japan 3-6 December 2006
3. Bergallo C, Jasovich A, Teglia O, et al. Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized Phase 3 comparison study with levofloxacin. Diagn. Microbiol. Infect. Dis. 63(1), 52-61 (2009)
4. Tanaseannu C, Bergallo C, Teglia O, et al. Integrated results of 2 Phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn. Microbiol. Infect. Dis. 61(3), 329-338 (2008) (Pubitemid 351858575)
5. Dartois N, Castaing N, Gandjini H, Cooper A. Tigecycline 313 Study Group. Tigecycline versus levofloxacin for the treatment of community-acquired pneumonia: European experience. J. Chemother. 20(Suppl. 1), 28-35 (2008)
6. Oliva MAE, Rekha A, Yellin A, et al. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [study ID numbers: 3074A1-301- WW; clinical trials. Gov identifier: NCT00081744]. BMC Infect. Dis. 5, 88 (2005)
7. Fomin P, Koalov S, Cooper A, et al. The efficacy and safety of tigecycline for the treatment of complicated intra-adominal infections the European experience. J. Chemother. 20(Suppl. 1), 12-19 (2008)
8. Breedt J, Teras J, Gardovskis J, et al. Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind Phase 3 comparison study with vancomycin-aztreonam. Antimicrob. Agents Chemother. 49(11), 4658-4666 (2005) (Pubitemid 41552597)
9. Sacchidanand S, Penn RL, Embil JM, et al. Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: results from a Phase 3, randomized, double-blind trial. Int. J. Infect. Dis. 9(5), 251-261 (2005) (Pubitemid 41196869)
10. Ellis-Grosse EJ, Babinchak T, Dartois N, Rose G, Loh E. The efficacy and safety of tigecycline in the treatment of skin and skin-structure infections: results of 2 double-blind Phase 3 comparison studies with vancomycin- aztreonam. Clin. Infect. Dis. 41(Suppl. 5), S341-S353 (2005) (Pubitemid 41170381)
11. Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin. Infect. Dis. 41(Suppl. 5), S354-S367 (2005) (Pubitemid 41170382)
12. Wilcox MH. Efficacy of tigecycline in complicated skin and skin structure infections and complicated intra-abdominal infections. J. Chemother. 17(Suppl. 1), 23-29 (2005) (Pubitemid 41686778)
13. Tombs NL. Tissue distribution of GAR-936, a broad-spectrum antibiotic, in male rats. Abstract book of: The 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society for Microbiology Publisher, DC, USA, 302 (1999)
14. Ji AJ, Saunders JP, Amorusi P, et al. A sensitive human bone assay for quantitation of tigecycline using LC-MS/MS. J. Pharm. Biomed. Anal. 48(3), 866-875 (2008)
15. Ji AJ, Saunders JP, Wadgaonkar ND, et al. A novel antibiotic bone assay by liquid chromatography/tandem mass spectrometry for quantitation of tigecycline in rat bone. J. Pharm. Biomed. Anal. 44(4), 970-979 (2007) (Pubitemid 47103248)
16. Li C, Sutherland CA, Nightingale CH, Nicolau DP. Quantitation of tigecycline, a novel glycylcycline [corrected] by liquid chromatography. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 811(2), 225-229 (2004) (Pubitemid 39446769)
17. Physicians Desk Reference: PDR-Tygacil for Injection (Wyeth) (2009) www.thomsonhc.com/pdrel/librarian/PFDefaultActionId/pdrcommon. IndexSearchTranslator#section15
18. FDA Guidance for industry, bioanalytical method validation (May 2001) www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070107.pdf