TY - JOUR
T1 - Cross-validation of a mass spectrometric-based method for the therapeutic drug monitoring of irinotecan
T2 - implementation of matrix-assisted laser desorption/ionization mass spectrometry in pharmacokinetic measurements
AU - Calandra, Eleonora
AU - Posocco, Bianca
AU - Crotti, Sara
AU - Marangon, Elena
AU - Giodini, Luciana
AU - Nitti, Donato
AU - Toffoli, Giuseppe
AU - Traldi, Pietro
AU - Agostini, Marco
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Irinotecan is a widely used antineoplastic drug, mostly employed for the treatment of colorectal cancer. This drug is a feasible candidate for therapeutic drug monitoring due to the presence of a wide inter-individual variability in the pharmacokinetic and pharmacodynamic parameters. In order to determine the drug concentration during the administration protocol, we developed a quantitative MALDI-MS method using CHCA as MALDI matrix. Here, we demonstrate that MALDI-TOF can be applied in a routine setting for therapeutic drug monitoring in humans offering quick and accurate results. To reach this aim, we cross validated, according to FDA and EMA guidelines, the MALDI-TOF method in comparison with a standard LC-MS/MS method, applying it for the quantification of 108 patients’ plasma samples from a clinical trial. Standard curves for irinotecan were linear (R2 ≥ 0.9842) over the concentration ranges between 300 and 10,000 ng/mL and showed good back-calculated accuracy and precision. Intra- and inter-day precision and accuracy, determined on three quality control levels were always
AB - Irinotecan is a widely used antineoplastic drug, mostly employed for the treatment of colorectal cancer. This drug is a feasible candidate for therapeutic drug monitoring due to the presence of a wide inter-individual variability in the pharmacokinetic and pharmacodynamic parameters. In order to determine the drug concentration during the administration protocol, we developed a quantitative MALDI-MS method using CHCA as MALDI matrix. Here, we demonstrate that MALDI-TOF can be applied in a routine setting for therapeutic drug monitoring in humans offering quick and accurate results. To reach this aim, we cross validated, according to FDA and EMA guidelines, the MALDI-TOF method in comparison with a standard LC-MS/MS method, applying it for the quantification of 108 patients’ plasma samples from a clinical trial. Standard curves for irinotecan were linear (R2 ≥ 0.9842) over the concentration ranges between 300 and 10,000 ng/mL and showed good back-calculated accuracy and precision. Intra- and inter-day precision and accuracy, determined on three quality control levels were always
KW - Bioanalytical methods
KW - Drug monitoring/drug screening
KW - Irinotecan
KW - MALDI-TOF
UR - http://www.scopus.com/inward/record.url?scp=84971006848&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84971006848&partnerID=8YFLogxK
U2 - 10.1007/s00216-016-9634-5
DO - 10.1007/s00216-016-9634-5
M3 - Article
AN - SCOPUS:84971006848
VL - 408
SP - 5369
EP - 5377
JO - Fresenius Journal of Analytical Chemistry
JF - Fresenius Journal of Analytical Chemistry
SN - 0016-1152
IS - 19
ER -