Volumetric Absorptive Microsampling to Enhance the Therapeutic Drug Monitoring of Tacrolimus and Mycophenolic Acid: A Systematic Review and Critical Assessment

Leino, Abbie D.; Takyi-Williams, John; Pai, Manjunath P.

doi:10.1097/ftd.0000000000001066

Cited by 5 publications

(3 citation statements)

References 117 publications

(287 reference statements)

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“…Many DBS assays for environmental exposure biomarkers (e.g., cotinine) were found to have minimal hematocrit effects. , Among mycotoxin DBS assays, hematocrit effects were negligible for analyses of OTA . Therefore, VTS may present the greatest value for therapeutic drug monitoring and pharmacokinetic studies where hematocrit effects are most significant. , Future work validating DBS assays should continue to investigate hematocrit effects and elucidate the value of VTS versus DBS/DSS sampling on a biomarker-by-biomarker basis.…”

Section: Discussionmentioning

confidence: 99%

Advancing Global Health Surveillance of Mycotoxin Exposures using Minimally Invasive Sampling Techniques: A State-of-the-Science Review

Jacobson,

Bae,

Kler

et al. 2024

Environ. Sci. Technol.

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Mycotoxins are a heterogeneous group of toxins produced by fungi that can grow in staple crops (e.g., maize, cereals), resulting in health risks due to widespread exposure from human consumption and inhalation. Dried blood spot (DBS), dried serum spot (DSS), and volumetric tip microsampling (VTS) assays were developed and validated for several important mycotoxins. This review summarizes studies that have developed these assays to monitor mycotoxin exposures in human biological samples and highlights future directions to facilitate minimally invasive sampling techniques as global public health tools. A systematic search of PubMed (MEDLINE), Embase (Elsevier), and CINAHL (EBSCO) was conducted. Key assay performance metrics were extracted to provide a critical review of the available methods. This search identified 11 published reports related to measuring mycotoxins (ochratoxins, aflatoxins, and fumonisins) using DBS/DSS and VTS assays. Multimycotoxin assays adapted for DBS/DSS and VTS have undergone sufficient laboratory validation for applications in large-scale population health and human biomonitoring studies. Future work should expand the number of mycotoxins that can be measured in multimycotoxin assays, continue to improve multimycotoxin assay sensitivities of several biomarkers with low detection rates, and validate multimycotoxin assays across diverse populations with varying exposure levels. Validated low-cost and ultrasensitive minimally invasive sampling methods should be deployed in human biomonitoring and public health surveillance studies to guide policy interventions to reduce inequities in global mycotoxin exposures.

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Section: Discussionmentioning

confidence: 99%

Advancing Global Health Surveillance of Mycotoxin Exposures using Minimally Invasive Sampling Techniques: A State-of-the-Science Review

Jacobson,

Bae,

Kler

et al. 2024

Environ. Sci. Technol.

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“…However, understanding the contribution of food is essential to optimize total drug exposure because dietary intake is more modifiable than chronobiology 51 . This is increasingly important as advances in remote monitoring expand the potential for home‐based collection of repeated samples 52‐59 . While outside the scope of this article, the potential chronopharmacodynamic effects must also be considered 10,22,25,60,61 …”

Section: Discussionmentioning

confidence: 99%

“…51 This is increasingly important as advances in remote monitoring expand the potential for home-based collection of repeated samples. [52][53][54][55][56][57][58][59] While outside the scope of this article, the potential chronopharmacodynamic effects must also be considered. 10,22,25,60,61…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Mixed‐Method Approach to Characterize the Source of Diurnal Tacrolimus Exposure Variability in Children: Systematic Review, Meta‐analysis, and Application to an Existing Data Set

Leino,

Magee,

Kershaw

et al. 2023

The Journal of Clinical Pharma

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Tacrolimus is widely reported to display diurnal variation in pharmacokinetic parameters with twice‐daily dosing. However, the contribution of chronopharmacokinetics versus food intake is unclear, with even less evidence in the pediatric population. The objectives of this study were to summarize the existing literature by meta‐analysis and evaluate the impact of food composition on 24‐hour pharmacokinetics in pediatric kidney transplant recipients. For the meta‐analysis, ten studies involving 253 individuals were included. The pooled effect sizes demonstrated significant differences in AUC0‐12 (SMD: 0.27, 95% CI: 0.03, 0.52) and Cmax (SMD: 0.75, 95% CI: 0.35, 1.15) between morning and evening dose administration. However, there was significant between‐study heterogeneity which was explained by food exposure. The effect size for Cmin was not significantly different overall (SMD: ‐0.09, 95% CI: ‐0.27, 0.09) or across the food exposure subgroups. A two‐compartment model with a lag time, linear clearance, and first‐order absorption best characterized the tacrolimus pharmacokinetics in pediatric participants. As expected, adding the time of administration and food composition covariates reduced the unexplained within‐subject variability for ka, but only caloric composition significantly reduced variability for Tlag. The available data suggest food intake is the major driver of diurnal variation in tacrolimus exposure, but the associated changes are not reflected by trough concentrations alone.This article is protected by copyright. All rights reserved

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Therapeutic drug monitoring of mycophenolic acid (MPA) using volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients: ultra-high-performance liquid chromatography-tandem mass spectrometry analytical method development, cross-validation, and clinical application

et al. 2023

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Background Mycophenolic acid (MPA) is widely used in posttransplant pharmacotherapy for pediatric patients after renal transplantation. Volumetric absorptive microsampling (VAMS) is a recent approach for sample collection, particularly during therapeutic drug monitoring (TDM). The recommended matrix for MPA determination is plasma (PL), and conversion between capillary-blood VAMS samples and PL concentrations is required for the appropriate interpretation of the results. Methods This study aimed to validate and develop a UHPLC-MS/MS method for MPA quantification in whole blood (WB), PL, and VAMS samples, with cross and clinical validation based on regression calculations. Methods were validated in the 0.10–15 µg/mL range for trough MPA concentration measurement according to the European Medicines Agency (EMA) guidelines. Fifty pediatric patients treated with MPA after renal transplantation were included in this study. PL and WB samples were obtained via venipuncture, whereas VAMS samples were collected after the fingerstick. The conversion from VAMSMPA to PLMPA concentration was performed using formulas based on hematocrit values and a regression model. Results LC–MS/MS methods were successfully developed and validated according to EMA guidelines. The cross-correlation between the methods was evaluated using Passing-Bablok regression, Bland–Altman bias plots, and predictive performance calculations. Clinical validation of the developed method was successfully performed, and the formula based on regression was successfully validated for VAMSMPA to PLMPA concentration and confirmed on an independent group of samples. Conclusions This study is the first development of a triple matrix-based LC–MS/MS method for MPA determination in the pediatric population after renal transplantation. For the first time, the developed methods were cross-validated with routinely used HPLC–DAD protocol. Graphical Abstract

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Volumetric Absorptive Microsampling to Enhance the Therapeutic Drug Monitoring of Tacrolimus and Mycophenolic Acid: A Systematic Review and Critical Assessment

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 5 publications

References 117 publications

Advancing Global Health Surveillance of Mycotoxin Exposures using Minimally Invasive Sampling Techniques: A State-of-the-Science Review

Advancing Global Health Surveillance of Mycotoxin Exposures using Minimally Invasive Sampling Techniques: A State-of-the-Science Review

A Comprehensive Mixed‐Method Approach to Characterize the Source of Diurnal Tacrolimus Exposure Variability in Children: Systematic Review, Meta‐analysis, and Application to an Existing Data Set

Therapeutic drug monitoring of mycophenolic acid (MPA) using volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients: ultra-high-performance liquid chromatography-tandem mass spectrometry analytical method development, cross-validation, and clinical application

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