Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development
Kramer et al.
The finding, in our words
The study found that blood concentrations of padsevonil measured using Mitra devices can reliably predict plasma concentrations with less than 9% mean bias, supporting the use of VAMS as a patient-centric alternative to venous sampling in decentralised trials. This validation strengthens confidence in microsampling for therapeutic drug monitoring where venous draws are impractical.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In 55 patients, four approaches to convert dried capillary blood concentrations to plasma equivalents were evaluated. All methods except haematocrit-based conversion yielded acceptable analytical and clinical agreement for paracetamol and metabolites, supporting the reliability of capillary microsampling for decentralised therapeutic drug monitoring.
Boffel et al., The AAPS journal (paywalled) · source ↗
The study validated a VAMS-based bioanalytical method using the Tasso OnDemand device for the drug gefapixant and demonstrated a mathematical bridging relationship with standard plasma assays, supporting its use in decentralised clinical trials.
Roadcap et al., Bioanalysis (paywalled) · source ↗
In lung and renal transplant recipients, VAMS sampling with LC-MS/MS quantification of mycophenolic acid and tacrolimus showed good linearity and accuracy, and with a haematocrit-adjusted conversion formula achieved clinical agreement in most samples; tacrolimus did not require haematocrit correction. The approach is virtually painless and enables richer sampling for more accurate drug exposure estimates, supporting decentralised therapeutic drug monitoring.
Juan et al., Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · source ↗
An LC-MS/MS method for tamoxifen and six metabolites in VAMS was developed and validated, with water prerinsing improving recoveries and poor room temperature stability but stability for at least 100 days at minus 80 degrees Celsius. Plasma to blood ratios were used to estimate plasma equivalent concentrations, and paired VAMS and plasma samples from ten breast cancer patients showed strong correlations and good agreement on Bland-Altman analysis, supporting reliable decentralised TDM.
Kuo et al., Analytical and bioanalytical chemistry (paywalled) · source ↗
The study validated an LC-MS/MS method for eight antiepileptic drugs and two metabolites in dried blood spot and VAMS formats, with satisfactory analytical performance and stability, and was the first to include the oxcarbazepine metabolite DHCB. In 80 paired patient samples, microsampling concentrations showed promising correlation with plasma, supporting decentralised therapeutic drug monitoring of antiepileptic treatment.
Cobo-Golpe et al., Journal of analytical toxicology · source ↗