scholarly journals Volumetric Absorptive Microsampling as a Sampling Alternative in Clinical Trials and Therapeutic Drug Monitoring During the COVID-19 Pandemic: A Review

2020 ◽  
Vol Volume 14 ◽  
pp. 5757-5771
Author(s):  
Yahdiana Harahap ◽  
Rasmina Diptasaadya ◽  
Denni Joko Purwanto
Keyword(s):  
Clinical Trials ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Volumetric Absorptive Microsampling

scholarly journals Therapeutic Drug Monitoring of Antiseizure Medications Using Volumetric Absorptive Microsampling: Where Are We?

2021 ◽  
Vol 14 (7) ◽  
pp. 627
Author(s):  
Annachiara D’Urso ◽  
Marcello Locatelli ◽  
Angela Tartaglia ◽  
Linda Molteni ◽  
Cristian D’Ovidio ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Minimally Invasive ◽  
Drug Monitoring ◽  
Sampling Technique ◽  
Capillary Blood ◽  
Therapeutic Drug ◽  
Sample Collection ◽  
Trained Personnel ◽  
Stability Data ◽  
Volumetric Absorptive Microsampling

Therapeutic drug monitoring (TDM) of antiseizure medications (ASMs) represents a valuable tool to establish an appropriate patient therapy, to collect important information about drugs’ interactions and to evaluate patient’s metabolic capabilities. In recent years, a new volumetric absorptive microsampling technique using VAMS® technology and Mitra® devices, consisting of a sampling technique for the collection of fixed-volume capillary blood, was developed. These new devices provide a new home-sampling technique for whole blood that has been spread out to simplify sample collection from finger-pricks. This review is aimed to compare published articles concerning the application of VAMS® in epilepsy and to identify the strengths and improvement points for the TDM of antiseizure medications. VAMS® allowed a minimally invasive blood sampling even in the absence of trained personnel. Good stability data have indicated that storage and delivery can be facilitated only for specific ASMs. Trueness and precision parameters have been evaluated, and the hematocrit (HCT) effect was minimized.

scholarly journals A whole blood microsampling assay for vancomycin: development, validation and application for pediatric clinical study

Bioanalysis ◽  
2020 ◽  
Vol 12 (18) ◽  
pp. 1295-1310
Author(s):  
Ganesh S Moorthy ◽  
Kevin J Downes ◽  
Christina Vedar ◽  
Athena F Zuppa
Keyword(s):  
Clinical Study ◽  
Therapeutic Drug Monitoring ◽  
Clinical Research ◽  
Clinical Data ◽  
Drug Monitoring ◽  
Whole Blood ◽  
Therapeutic Drug ◽  
Human Whole Blood ◽  
Assay Conditions ◽  
Volumetric Absorptive Microsampling

Background: Vancomycin is a commonly used antibiotic, which requires therapeutic drug monitoring to ensure optimal treatment. Microsampling assays are attractive tools for pediatric clinical research and therapeutic drug monitoring. Results: A LC–MS/MS method for the quantification of vancomycin in human whole blood employing volumetric absorptive microsampling (VAMS®) devices (20 μl) was developed and validated. Vancomycin was stable in human whole blood VAMS under assay conditions. Stability for vancomycin was established for at least 160 days as dried microsamples at -78°C. Conclusion: This method is currently being utilized for the quantitation of vancomycin in whole blood VAMS for an ongoing pediatric clinical study and representative clinical data are reported.

Lessons from isavuconazole therapeutic drug monitoring at a United Kingdom Reference Center

2020 ◽  
Vol 58 (7) ◽  
pp. 996-999 ◽  
Author(s):  
Andrew M Borman ◽  
Jessica M Hughes ◽  
Debra Oliver ◽  
Mark Fraser ◽  
Julie Sunderland ◽  
...  
Keyword(s):  
Clinical Trials ◽  
United Kingdom ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Serum Concentrations ◽  
Reference Center ◽  
Prolonged Therapy ◽  
Dosing Regimens

Abstract We determined isavuconazole serum concentrations for 150 UK patients receiving standard isavuconazole dosing regimens, including serial therapeutic drug monitoring for several patients on prolonged therapy. Mean trough isavuconazole concentrations in these patients were virtually identical to those reported previously from clinical trials, although greater variability was seen in patients below 18 years of age. Serial monitoring in patients receiving prolonged therapy suggested gradual, near-linear accumulation of the drug over many weeks.

scholarly journals Isavuconazole Concentration in Real-World Practice: Consistency with Results from Clinical Trials

2018 ◽  
Vol 62 (7) ◽  
Author(s):  
David Andes ◽  
Laura Kovanda ◽  
A. Desai ◽  
Therese Kitt ◽  
M. Zhao ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Real World ◽  
Drug Monitoring ◽  
Antifungal Agents ◽  
Plasma Concentrations ◽  
Therapeutic Drug ◽  
Clinical Use

ABSTRACT Clinical use of voriconazole, posaconazole, and itraconazole revealed the need for therapeutic drug monitoring (TDM) of plasma concentrations of these antifungal agents. This need for TDM was not evident from clinical trials. In order to establish whether this requirement also applies to isavuconazole, we examined the plasma concentrations of 283 samples from patients receiving isavuconazole in clinical practice and compared the values with those from clinical trials. The concentration distributions from real-world use and clinical trials were nearly identical (>1 μg/ml in 90% of patients). These findings suggest that routine TDM may not be necessary for isavuconazole in most instances.

scholarly journals Quality Assessment for Therapeutic Drug Monitoring in AIDS Clinical Trials Group (ACTG 5146): A Multicenter Clinical Trial

2010 ◽  
Vol 32 (4) ◽  
pp. 458-466 ◽  
Author(s):  
Robin DiFrancesco ◽  
Susan Rosenkranz ◽  
A Lisa Mukherjee ◽  
Lisa M Demeter ◽  
Hongyu Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Therapeutic Drug Monitoring ◽  
Quality Assessment ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Multicenter Clinical Trial ◽  
Aids Clinical Trials

Diagnose und Monitoring bei chronisch-entzündlicher Darmerkrankung

2018 ◽  
Vol 75 (5) ◽  
pp. 316-328
Author(s):  
Christian Ansprenger ◽  
Emanuel Burri
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Morbus Crohn ◽  
Therapeutic Drug ◽  
Körperliche Untersuchung

Zusammenfassung. Die Diagnose und auch die Überwachung von chronisch entzündlichen Darmerkrankungen ruht auf mehreren Säulen: Anamnese, körperliche Untersuchung, Laborwerte (im Blut und Stuhl), Endoskopie, Histologie und Bildgebung. Die Diagnose kann nicht anhand eines einzelnen Befundes gestellt werden. In den letzten Jahren hat sich das Therapieziel weg von klinischen Endpunkten hin zu endoskopischen und sogar histologischen Endpunkten entwickelt. Für einige dieser neuen Therapieziele existiert allerdings noch keine allgemein gültige Definition. Regelmässige Endoskopien werden von Patienten schlecht toleriert, weshalb Surrogat-Marker wie Calprotectin untersucht wurden und eine gute Korrelation mit der mukosalen Entzündungsaktivität nachgewiesen werden konnte. Entsprechend zeigte sich bei Morbus Crohn eine Algorithmus-basierte Therapiesteuerung – unter anderem basierend auf Calprotectin – einer konventionellen Therapiesteuerung überlegen. Die Überwachung der medikamentösen Therapie («Therapeutic Drug Monitoring» [TDM]) ist ein zweites Standbein des Monitoring von chronisch entzündlichen Darmerkrankungen. Mit zunehmendem Einsatz vor allem der Biologika-Therapien wurden sowohl reaktives TDM (in Patienten mit klinischem Rezidiv) als auch proaktives TDM (in Patienten in Remission / stabiler Erkrankung) untersucht und haben (teilweise) Eingang in aktuelle Richtlinien gefunden. Zukünftige Studien werden die vorgeschlagenen Therapieziele besser definieren und den Nutzen der medikamentösen Therapieüberwachung auf den Krankheitsverlauf weiter untersuchen müssen.

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