“…The disadvantage of TDM based on plasma samples is represented by the discomfort caused to patients to obtain venous samples by using sampling procedures that cannot be applied at all to pediatrics patients and/or newborns, limiting the widespread of TDM in such population. To overcome these issue, new microsampling devices are described in literature [34][35][36]. These systems allow to collect a known volume of blood by means of microfluidic system, nullifying the HCT and drop volume effects on the analytes determination [17,[19][20][21].…”
The aim of this work is to evaluate volumetric absorptive microsampling (VAMS) from capillary blood as an alternative strategy for therapeutic drug monitoring (TDM) in patients treated with the newly available GW-purified form of cannabidiol (Epidiolex®). A fast ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) coupled to an online sample preparation system analysis was carried out on a Thermo Scientific Ultimate 3000 LC system coupled to a TSQ Quantiva triple quadrupole for the quantification of cannabidiol (CBD) and, in addition, delta-9-tetrahydrocannabinol (Δ9-THC). After validation using European Medicine Agency (EMA) guidelines the method was applied to samples obtained by finger prick of five pediatric patients treated with Epidiolex® and the results were compared to those obtained from venous blood and plasma. The method is linear in the range of 1–800 µg/L for both CBD and THC with intra- and inter-day precisions ranging from 5% to 14% and accuracies from −13% to +14% starting from 30 µL of sample. Stability in VAMS is ensured for up to 4 weeks at 25 °C thus allowing simple delivery. There was no difference (p = 0.69) between concentrations of CBD measured from VAMS sampled from capillary or venous blood (range: 52.19–330.14 or 72.15–383.45 µg/L) and those obtained from plasma (range: 64.3–374.09 µg/L) The VAMS-LC-MS/MS method represents a valid alternative strategy for therapeutic drug monitoring of patients treated with Epidiolex®.
“…The disadvantage of TDM based on plasma samples is represented by the discomfort caused to patients to obtain venous samples by using sampling procedures that cannot be applied at all to pediatrics patients and/or newborns, limiting the widespread of TDM in such population. To overcome these issue, new microsampling devices are described in literature [34][35][36]. These systems allow to collect a known volume of blood by means of microfluidic system, nullifying the HCT and drop volume effects on the analytes determination [17,[19][20][21].…”
The aim of this work is to evaluate volumetric absorptive microsampling (VAMS) from capillary blood as an alternative strategy for therapeutic drug monitoring (TDM) in patients treated with the newly available GW-purified form of cannabidiol (Epidiolex®). A fast ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) coupled to an online sample preparation system analysis was carried out on a Thermo Scientific Ultimate 3000 LC system coupled to a TSQ Quantiva triple quadrupole for the quantification of cannabidiol (CBD) and, in addition, delta-9-tetrahydrocannabinol (Δ9-THC). After validation using European Medicine Agency (EMA) guidelines the method was applied to samples obtained by finger prick of five pediatric patients treated with Epidiolex® and the results were compared to those obtained from venous blood and plasma. The method is linear in the range of 1–800 µg/L for both CBD and THC with intra- and inter-day precisions ranging from 5% to 14% and accuracies from −13% to +14% starting from 30 µL of sample. Stability in VAMS is ensured for up to 4 weeks at 25 °C thus allowing simple delivery. There was no difference (p = 0.69) between concentrations of CBD measured from VAMS sampled from capillary or venous blood (range: 52.19–330.14 or 72.15–383.45 µg/L) and those obtained from plasma (range: 64.3–374.09 µg/L) The VAMS-LC-MS/MS method represents a valid alternative strategy for therapeutic drug monitoring of patients treated with Epidiolex®.
“…For drug development, preclinical and clinical trial, drug concentration measurement in a representative specimen is the decisive factor. Cutting‐edge detection techniques and enhanced throughput methods based on mass spectrometric analysis have expanded the utility of microsampling 77,78 . The utility of DBS and VAMS in the quantitation of various therapeutic agents has been well established now 79,80 .…”
Section: Applications Of Microsampling In the Development Of Treatmentsmentioning
confidence: 99%
“…Cutting-edge detection techniques and enhanced throughput methods based on mass spectrometric analysis have expanded the utility of microsampling. 77,78 The utility of DBS and VAMS in the quantitation of various therapeutic agents has been well established now. 79,80 Quantitation of analyte concentration in various biological specimens is demonstrated using microsampling techniques in drug development, preclinical and clinical trials.…”
Section: Applications Of Microsampling In the Development Of Treatmentsmentioning
The outbreak of the new coronavirus disease changed the world upside down. Every day, millions of people were subjected to diagnostic testing for Covid‐19, all over the world. Molecular tests helped in the diagnosis of current infection by detecting the presence of viral genome whereas serological tests helped in detecting the presence of antibody in blood as well as contributed to vaccine development. This testing helped in understanding the immunogenicity, community prevalence, geographical spread and conditions post‐infection. However, with the contagious nature of the virus, biological specimen sampling involved the risk of transmission and spread of infection. Clinic or pathology visit was the most concerning part. Trained personnel and resources was another barrier. In this scenario, microsampling played an important role due to its most important advantage of remote, contactless, small volume and self‐sampling. Minimum requirements for sample storage and ease of shipment added value in this situation. The highly sensitive instruments and validated assay formats assured the accuracy of results and stability of samples. Microsampling techniques are contributing effectively to the Covid‐19 pandemic by reducing the demand for clinical staff in population‐level testing. The validated and established applications supported the use of microsampling in diagnosis, therapeutic drug monitoring, development of treatment or vaccines and clinical trials for Covid‐19.
“…The sampling procedure is quite straightforward and can be carried out at home by patients or other people with minimal training. Like most microsampling techniques, VAMS has been developed and validated for blood sampling, but can be applied with satisfactory results to other matrices [ [16] , [17] , [18] , [19] ]. Fig.…”
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