Practical and efficient strategy for evaluating oral absolute bioavailability with an intravenous microdose of a stable isotopically-labeled drug using a selected reaction monitoring mass spectrometry assay

Analytical Chemistry

Volumn 84, Issue 22, 2012, Pages 10031-10037

  Jiang, Hao ^a   Zeng, Jianing ^a   Li, Wenying ^b   Bifano, Marc ^c   Gu, Huidong ^a   Titsch, Craig ^a   Easter, John ^c   Burrell, Richard ^c   Kandoussi, Hamza ^a   Aubry, Anne Françoise ^a   Arnold, Mark E ^a  

^a Bioanalytical Sciences/Analytical and Bioanalytical Sciences   (United States)

^b Biotransformation/Pharmaceutical Candidate Optimization   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCELERATOR MASS SPECTROMETRY; BIOANALYTICAL; BIOAVAILABILITY STUDY; CHEMICAL SYNTHESIS; DATA QUALITY; EFFICIENT STRATEGY; INTERNAL STANDARDS; ISOTOPE EFFECT; ISOTOPICALLY LABELED; MICRODOSE; MICRODOSING; SELECTED REACTION MONITORING; THERAPEUTIC DOSE;

BIOCHEMISTRY; ISOTOPES; MASS SPECTROMETRY;

DRUG DOSAGE;

BMS-790052; DACLATASVIR; IMIDAZOLE DERIVATIVE;

ARTICLE; BIOAVAILABILITY; DRUG DESIGN; HUMAN; INTRAVENOUS ADMINISTRATION; ISOTOPE LABELING; MASS SPECTROMETRY; METHODOLOGY; REPRODUCIBILITY;

ADMINISTRATION, INTRAVENOUS; BIOLOGICAL AVAILABILITY; DRUG DESIGN; HUMANS; IMIDAZOLES; ISOTOPE LABELING; MASS SPECTROMETRY; REPRODUCIBILITY OF RESULTS;

EID: 84869427575     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/ac3024558     Document Type: Article

References (26)

1. Ings, R. M. Bioanalysis 2009, 1, 1293-1305
2. Wong, J.; Brugger, A.; Khare, A.; Chaubal, M.; Papadopoulos, P.; Rabinow, B; Kipp, J; Ning, J. Adv. Drug Delivery Rev. 2008, 60, 939-954
3. Wolen, R. L. J. Clin. Pharmacol. 1986, 26, 419-424
4. Preston, S. L.; Drusano, G. L.; Glue, P.; Nash, J.; Gupta, S. K.; McNamara, P. Antimicrob. Agents Chemother. 1999, 43, 2451-2456
5. Finglas, P. M.; Witthöft, C. M.; Vahteristo, L.; Wright, A. J.; Southon, S.; Mellon, F. A.; Ridge, B.; Maunder, P. J. Nutr. 2002, 132, 936-939
6. Parr, A.; Gupta, M.; Montague, T. H.; Hoke, F. AAPS J. 2012, 14, 639-645
7. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2006, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm078933.pdf. Accessed May 18, 2012.
8. Barker, J.; Garner, R. C. Rapid Commun. Mass Spectrom. 1999, 13, 285-293
9. Garner, R. C. Curr. Drug Metab. 2000, 1, 205-213
10. Lappin, G.; Stevens, L. Expert. Opin. Drug Metab. Toxicol. 2008, 4, 1021-1033
11. Gao, L.; Li, J.; Kasserra, C.; Song, Q.; Arjomand, A.; Hesk, D.; Chowdhury, S. K. Anal.Chem. 2011, 83, 5607-5616
12. Duan, X.; Weinstock-Guttman, B.; Wang, H.; Bang, E.; Li, J.; Ramanathan, M.; Qu, J. Anal. Chem. 2010, 82, 2488-2497
13. Dahal, U. P.; Jones, J. P.; Davis, J. A.; Rock, D. A. Drug Metab. Dispos. 2011, 39, 2355-2360
14. Niwa, M. Bioanalysis 2012, 4, 213-220
15. Rudewicz, P. J. Bioanalysis 2011, 3, 1663-1671
16. Gao, M.; Nettles, R. E.; Belema, M.; Snyder, L. B.; Nguyen, V. N.; Fridell, R. A.; Serrano-Wu, M. H.; Langley, D. R.; Sun, J. H.; O'Boyle, D. R, 2nd; Lemm, J. A.; Wang, C.; Knipe, J. O.; Chien, C.; Colonno, R. J.; Grasela, D. M.; Meanwell, N. A.; Hamann, L. G. Nature 2010, 465, 96-100
17. Gu, H.; Wang, J.; Aubry, A. F.; Jiang, H.; Zeng, J.; Easter, J.; Wang, J. S.; Dockens, R.; Bifano, M.; Burrell, R.; Arnold, M. E. Anal. Chem. 2012, 84, 4844-4850
18. Van Langenhove, A. J. Clin. Pharmacol. 1986, 26, 383-389
19. Sharma, R.; Strelevitz, T. J.; Gao, H.; Clark, A. J.; Schildknegt, K.; Obach, R. S.; Ripp, S. L.; Spracklin, D. K.; Tremaine, L. M.; Vaz, A. D. Drug Metab. Dispos. 2012, 40, 625-634
20. Isotope Pattern Calculator v4.0. http://yanjunhua.tripod.com/pattern.htm. Accessed May 20, 2012.
21. Guidance for Industry: Bioanalytical Method Validation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070107.pdf. Accessed May 21, 2012.
22. Jiang, H.; Zeng, J.; Kandoussi, H.; Liu, Y.; Wang, X.; Bifano, M.; Cojocaru, L.; Ryan, J.; Arnold, M. E. J. Chromatogr., A 2012, 1245, 117-121
23. Yergey, J. A. Int. J. Mass Spectrom. Ion Phys. 1983, 52, 337-349
24. Kubinyi, H. Anal. Chim. Acta 1991, 247, 107-119
25. Rockwood, A. L.; Van Orden, S. L.; Smith, R. D. Anal. Chem. 1995, 67, 2699-2704
26. Sheffield ChemPuter: Isotope Patterns Calculator. http://winter.group. shef.ac.uk/chemputer/isotopes.html. Accessed May 26, 2012.