Rapid determination of granisetron in human plasma by liquid chromatography coupled to tandem mass spectrometry and its application to bioequivalence study

Journal of Pharmaceutical and Biomedical Analysis

Volumn 42, Issue 4, 2006, Pages 464-473

  Jiang, Yunyun ^a   Lin, Mei ^b   Fan, Guorong ^a   Chen, Yi ^a   Li, Zhen ^c   Zhao, Weiquan ^a   Wu, Yutian ^a   Hu, Jinhong ^c  

^a SECOND MILITARY MEDICAL UNIVERSITY   (China)

^b SHANGHAI INSTITUTE FOR FOOD AND DRUG CONTROL   (China)

^c SECOND MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

Bioequivalence; Granisetron; LC MS MS; Pharmacokinetics; Plasma

Indexed keywords

GRANISETRON; RIZATRIPTAN;

ACCURACY; ADULT; ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG FORMULATION; DRUG STABILITY; DRUG STRUCTURE; ELECTROSPRAY; EXTRACTION; HIGH THROUGHPUT SCREENING; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; LIQUID CHROMATOGRAPHY; LIQUID LIQUID EXTRACTION; MALE; NORMAL HUMAN; PRIORITY JOURNAL; SINGLE BLIND PROCEDURE; TABLET; TANDEM MASS SPECTROMETRY;

ADMINISTRATION, ORAL; ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; GRANISETRON; HUMANS; MALE; REPRODUCIBILITY OF RESULTS; SEROTONIN ANTAGONISTS; SINGLE-BLIND METHOD; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 33748562522     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.05.001     Document Type: Article

References (18)

1. Sanger G.J., and Nelson P.R. Eur. J. Pharmacol. 159 (1989) 113-124
2. Upward J.W., Arnold B.D.C., Link C., Pierce D.M., Allen A., and Tasker T.C.G. Eur. J. Cancer 26 (1990) S12-S15
3. Carmichael J., Cantwell B.M.J., Edwards C.M., Zussman B.D., Thompson S., Rapeport W.G., and Harris A.L. Cancer Chemother. Pharmacol. 24 (1989) 45-49
4. Aapro M. Oncologist 9 (2004) 673-686
5. Huang C.T., Chen C.F., and Tsai T.H. Life Sci. 64 (1999) 1921-1931
6. Boppana V.K. J. Chromatogr. A 692 (1995) 195-202
7. Huang C.T., Chen K.C., Chen C.F., and Tsai T.H. J. Chromatogr. B 716 (1998) 251-255
8. Wada I., Satoh M., Takeda T., Nakabayashi T., Honma T., Saitoh H., Takada M., and Hirano K. Biol. Pharm. Bull. 21 (1998) 535-537
9. McElvain J.S., Vandiver V.J., and Eichemeier L.S. J. Pharm. Biomed. Anal. 15 (1997) 513-521
10. Pinguet F., Bressolle F., Martel P., Salabert D., and Astre C. J. Chromatogr. B Biomed. Appl. 675 (1996) 99-105
11. Allen A., Asgill C.C., Pierce D.M., Upward J., and Zussman B.D. Eur. J. Clin. Pharmacol. 46 (1994) 159-162
12. Cupissol D., Bressolle F., Adenis L., Carmichael J., Bessell E., Allen A., Wargenau M., and Romain D. J. Pharm. Sci. 82 (1993) 1281-1284
13. Capacio B.R., Byers C.E., Jackson T.K., and Matthews R.L. J. Anal. Toxicol. 17 (1993) 151-155
14. Boppana V.K., Miller-Stein C., and Schaefer W.H. J. Chromatogr. B 678 (1996) 227-236
15. R.V.S. Nirogi, V.N. Kandikere, M. Shukla, K. Mudigonda, S. Maurya, R. Boosi, Biomed. Chromatogr. (2006) [Epub ahead of print].
16. FDA Guidance for Industry, Biaoavaliability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Ressearch (CDER), 2000, (website: http://www.fda.gov/cder/guidance/index.htm).
17. FDA Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001, (website: http://www.fda.gov/cder/guidance/index.htm).
18. FDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001, (website: http://www.fda.gov/cder/guidance/index.htm).