2025 · Clinical and Translational Science · open access
A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient-Centric Microsampling
Shahin et al.
The finding, in our words
A head-to-head pharmacokinetic comparison of conventional venous sampling against patient-centric microsampling: exactly the bridging study regulators now expect before microsampled data supports an endpoint.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
Capillary blood collection using liquid and dried microsampling devices yielded pharmacokinetic profiles comparable to venous sampling for two monoclonal antibodies and a small molecule, whereas haematocrit correction was necessary for dried formats and bridging was ineffective for hydroxychloroquine. The findings demonstrate the bioanalytical feasibility and patient acceptability of remote microsampling tools for pharmacokinetic evaluations in decentralised clinical trials.
The study found that capillary microtube samples showed perfect correlation, R 1.00, and narrow limits of agreement with venous blood for IgG monitoring, making them a viable alternative. Dried blood spots showed only moderate correlation, R 0.77, and broad limits of agreement, which the authors state makes them unsuitable for routine diagnostics.
Targeted proteomic evaluation of a novel finger-prick dried plasma device demonstrated strong quantitative correlation with conventional plasma (R = 0.99) and precision under 10% CV for 80% of quantified peptides across healthy donors. Quantified targets also remained stable during room temperature storage for up to 232 days, supporting its use for decentralised biomarker monitoring.
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.
At-home capillary microsampling carried pharmacokinetic sampling across the Paxlovid phase II/III programme, with fewer than 3% of more than 800 samples unusable, and the resulting data supported the Emergency Use Authorization and subsequent FDA approval: remotely collected samples accepted in a registrational filing.