Determination of unbound vismodegib (GDC-0449) concentration in human plasma using rapid equilibrium dialysis followed by solid phase extraction and high-performance liquid chromatography coupled to mass spectrometry

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 879, Issue 22, 2011, Pages 2119-2126

  Deng, Yuzhong ^a   Wong, Harvey ^a   Graham, Richard A ^a   Liu, Wenbin ^b   Shen, Heuy Shin ^b   Shi, Yao ^c   Wang, Laixin ^c   Meng, Min ^c   Malhi, Vikram ^a   Ding, Xiao ^a   Dean, Brian ^a  

^a GENENTECH INC   (United States)

^b QPS LLC   (United States)

^c Northwest Toxicology Inc   (United States)

Author keywords

GDC 0449; Hedgehog pathway inhibitor; LC MS MS; RED device; Vismodegib

Indexed keywords

GDC-0449; LC-MS/MS; PATHWAY INHIBITORS; RED DEVICE; VISMODEGIB;

DIALYSIS; ELECTROSPRAY IONIZATION; LINEAR REGRESSION; LIQUID CHROMATOGRAPHY; LIQUIDS; MASS SPECTROMETRY; PLASMA (HUMAN); PLASMAS;

EXTRACTION;

VISMODEGIB;

ACCURACY; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DILUTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG STABILITY; ELECTROSPRAY MASS SPECTROMETRY; EQUILIBRIUM DIALYSIS; FEMALE; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; LIMIT OF QUANTITATION; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; POSITIVE ION ELECTROSPRAY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RAPID EQUILIBRIUM DIALYSIS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SINGLE DRUG DOSE; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; VALIDATION STUDY;

ANALYSIS OF VARIANCE; ANILIDES; ANTINEOPLASTIC AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, REVERSE-PHASE; DIALYSIS; DRUG STABILITY; FEMALE; HUMANS; LINEAR MODELS; MALE; PROTEIN BINDING; PYRIDINES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY;

ERINACEIDAE;

EID: 79959861661     PISSN: 15700232     EISSN: 1873376X     Source Type: Journal    
DOI: 10.1016/j.jchromb.2011.05.048     Document Type: Article

References (13)

1. Dijkgraaf G.J., Alicke B., Weinmann L., Januario T., West K., Modrusan Z., Burdick D., Goldsmith R., Robarge K., Sutherlin D., Scales S.J., Gould S.E., Yauch R.L., de Sauvage F.J. Cancer Res. 2010, 71:435.
2. Robarge K.D., Brunton S.A., Castanedo G.M., Cui Y., Dina M.S., Goldsmith R., Gould S.E., Guichert O., Gunzner J.L., Halladay J., Jia W., Khojasteh C., Koehler M.F., Kotkow K., La H., Lalonde R.L., Lau K., Lee L., Marshall D., Marsters J.C., Murray L.J., Qian C., Rubin L.L., Salphati L., Stanley M.S., Stibbard J.H., Sutherlin D.P., Ubhayaker S., Wang S., Wong S., Xie M. Bioorg. Med. Chem. Lett. 2009, 19:5576.
3. Rudin C.M., Hann C.L., Laterra J., Yauch R.L., Callahan C.A., Fu L., Holcomb T., Stinson J., Gould S.E., Coleman B., LoRusso P.M., Von Hoff D.D., de Sauvage F.J., Low J.A. N. Engl. J. Med. 2009, 361:1173.
4. Yauch R.L., Dijkgraaf G.J., Alicke B., Januario T., Ahn C.P., Holcomb T., Pujara K., Stinson J., Callahan C.A., Tang T., Bazan J.F., Kan Z., Seshagiri S., Hann C.L., Gould S.E., Low J.A., Rudin C.M., de Sauvage F.J. Science 2009, 326:572.
5. Lorusso P.M., Rudin C.M., Reddy J.C., Tibes R., Weiss G.J., Borad M.J., Hann C.L., Brahmer J.R., Chang I., Darbonne W.C., Graham R.A., Zerivitz K.L., Low J., Von Hoff D.D. Clin. Cancer Res. 2011, 17:2502.
6. Von Hoff D.D., LoRusso P.M., Rudin C.M., Reddy J.C., Yauch R.L., Tibes R., Weiss G.J., Borad M.J., Hann C.L., Brahmer J.R., Mackey H.M., Lum B.L., Darbonne W.C., Marsters J.C., de Sauvage F.J., Low J.A. N. Engl. J. Med. 2009, 361:1164.
7. Graham R.A., Lum B.L., Cheeti S., Jin J.Y., Jorga K., Von Hoff D.D., Rudin C.M., Reddy J.C., Low J., Lorusso P.M. Clin. Cancer Res. 2011, 17:2512.
8. Pacifici G.M., Viani A. Clin. Pharmacokinet. 1992, 23:449.
9. Kariv I., Cao H., Oldenburg K.R. J. Pharm. Sci. 2001, 90:580.
10. Wan H., Rehngren M. J. Chromatogr. A 2006, 1102:125.
11. Waters N.J., Jones R., Williams G., Sohal B. J. Pharm. Sci. 2008, 97:4586.
12. Ding X., Chou B., Graham R.A., Cheeti S., Percey S., Matassa L.C., Reuschel S.A., Meng M., Liu S., Voelker T., Lum B.L., Rudewicz P.J., Hop C.E. J. Chromatogr. B 2010, 878:785.
13. Wong H., Chen J.Z., Chou B., Halladay J.S., Kenny J.R., La H., Marsters J.C., Plise E., Rudewicz P.J., Robarge K., Shin Y., Wong S., Zhang C., Khojasteh S.C. Xenobiotica 2009, 39:850.