Validation and Comparison of Two Analytical Methods for Imatinib Therapeutic Drug Monitoring

Alaejos, Álvaro Corral; Cabrera, Sandra; Rodríguez, Beatriz Castaño; Castañeda, Aránzazu Zarzuelo

doi:10.1007/s10337-021-04041-y

Cited by 10 publications

(4 citation statements)

References 25 publications

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“…It is commonly used in comparative studies, where compared variables are the subject of random error, which is not taken into account in the least-squares regression method [ 16 , 17 ]. Examples of use of this type of regression might be found in clinical chemistry [ 18 , 19 ] and bioanalytical analysis [ 20 ]. Application of Deming regression requires a calculation of the ratio between squared standard deviations of both variables [ 21 ].…”

Section: Resultsmentioning

confidence: 99%

An Automated Hydrodynamically Mediated Technique for Preparation of Calibration Solutions via Capillary Electrophoresis System as a Promising Alternative to Manual Pipetting

et al. 2021

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In this paper, a novel procedure for preparing calibration solutions for capillary electrophoresis (CE)-based quantitative analysis is proposed. Our approach, named the automated hydrodynamically mediated technique (AHMT), uses a capillary and a pressure system to deliver the expected amount of working solution and diluent directly to a sample vial. As a result, calibration solutions are prepared automatically inside the CE instrument, without any or with minimal manual operation. Two different modes were tested: forward and reverse, differing in the direction of hydrodynamic flow. The calibration curves obtained for a model mixture of analytes using AHMT were thorough compared to the standard procedure based on manual pipetting. The results were consistent, though the volume of obtained calibration solutions and the potential risk of random errors were significantly minimized by AHMT. Its effectiveness was further enhanced by the application of SCIEX® nanoVials, reducing the actual volume of calibration solutions down to 10 μL.

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Section: Resultsmentioning

confidence: 99%

An Automated Hydrodynamically Mediated Technique for Preparation of Calibration Solutions via Capillary Electrophoresis System as a Promising Alternative to Manual Pipetting

et al. 2021

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“…The analytical method was successfully validated in terms of linearity, accuracy and precision within the range of 250-3000 ng/mL following the European Medicines Agency (EMA) and Food and the Drug Administration (FDA) recommendations for the validation of analytical methods in biological fluids. 33,34 Overall precision and accuracy were lower than 6% in all the samples evaluated. 35…”

Section: Bioanalytical Methodsmentioning

confidence: 93%

External evaluation of population pharmacokinetic models of imatinib in adults diagnosed with chronic myeloid leukaemia

Alaejos

Castañeda

Cabrera

et al. 2021

Brit J Clinical Pharma

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Imatinib is considered the standard first-line treatment in newly diagnosed patients with chronic-phase myeloid leukaemia (CML). Several imatinib population pharmacokinetic (popPK) models have been developed. However, their predictive performance has not been well established when extrapolated to different populations. Therefore, this study aimed to perform an external evaluation of available imatinib popPK models developed mainly in adult patients, and to evaluate the improvement in individual model-based predictions through Bayesian forecasting computed by each model at different treatment occasions. Methods: A literature review was conducted through PubMed and Scopus to identify popPK models. Therapeutic drug monitoring data collected in adult CML patients treated with imatinib was used for external evaluation, including prediction-and simulated-based diagnostics together with Bayesian forecasting analysis. Results: Fourteen imatinib popPK studies were included for model-performance evaluation. A total of 99 imatinib samples were collected from 48 adult CML patients undergoing imatinib treatment with a minimum of one plasma concentration measured at steady-state between January 2016 and December 2020. The model proposed by Petain et al showed the best performance concerning prediction-based diagnostics in the studied population. Bayesian forecasting demonstrated a significant improvement in predictive performance at the second visit. Inter-occasion variability contributed to reducing bias and improving individual model-based predictions. Conclusions: Imatinib popPK studies developed in Caucasian subjects including α1-acid glycoprotein showed the best model performance in terms of overall bias and precision. Moreover, two imatinib samples from different visits appear sufficient to reach an adequate model-based individual prediction performance trough Bayesian forecasting.

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“…Therefore, the HPLC-UV/PDA method emerges as a rapid, economical, simple, accurate, precise, and reliable analytical technique for routine quantification of TKIs in clinical samples. Structurally speaking, TKIs exhibit characteristic absorption ranges at the wavelength of 230–326 nm for imatinib [ [99] , [100] , [101] , [102] , [103] , [104] , [105] ], 260–325 nm for dasatinib [ [106] , [107] , [108] , [109] , [110] ], 235–265.5 nm for sorafenib [ 30 , 102 , 111 ], 265–385 nm for nintedanib [ 112 , 113 ], 277 nm for sunitinib [ 114 ], etc. Sakhi et al [ 30 ] developed a sensitive HPLC/UV method for the determination of sorafenib in standard solutions and spiked plasma.…”

Section: Methodsmentioning

confidence: 99%

“…The parameter was optimized using a 3-level factorial design approach, and the best results were obtained under the following conditions: C 18 column, ammonium format buffer consisting of acetonitrile (28.19:71.81, V / V ), and buffer with pH 3. This optimized method was successfully applied to a pharmacokinetic study, demonstrating high recovery (99.91%), specificity (99.94%), precision (RSD < 0.543%), and robustness (RSD < 0.500%) ( Table S1 ) [ 2 , 3 , 5 , 8 , 12 , [15] , [16] , [17] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [37] , [38] , [39] , 41 , [48] , [49] , [50] , 52 , 54 , 55 , 61 , 63 , 64 , 76 , 80 , 83 , 84 , 86 , [88] , [89] , [90] , [91] , [92] , [93] , [94] , [95] , [97] , [98] , [99] , [100] , [101] , [102] , [103] , [104] , [105] , 109 , [111] , [112] , [113] , [114] ,…”

Section: Methodsmentioning

confidence: 99%

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

Chen,

Zhang,

Zhang

et al. 2024

Journal of Pharmaceutical Analysis

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Validation and Comparison of Two Analytical Methods for Imatinib Therapeutic Drug Monitoring

Cited by 10 publications

References 25 publications

An Automated Hydrodynamically Mediated Technique for Preparation of Calibration Solutions via Capillary Electrophoresis System as a Promising Alternative to Manual Pipetting

An Automated Hydrodynamically Mediated Technique for Preparation of Calibration Solutions via Capillary Electrophoresis System as a Promising Alternative to Manual Pipetting

External evaluation of population pharmacokinetic models of imatinib in adults diagnosed with chronic myeloid leukaemia

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

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