2024 · Journal of pharmaceutical and biomedical analysis · paywalled
Evaluation of low volume sampling devices for a pharmacodynamic biomarker analysis: Challenges and solutions
Yang et al.
The finding, in our words
Low volume sampling devices showed good concordance with venous serum for measuring the pharmacodynamic biomarker sMAdCAM-1, but dried blood samples required substantial dilution to overcome buffer interference, which was mitigated by using a highly sensitive Simoa assay. The study demonstrates that while these devices have potential for decentralised clinical trials, careful validation is needed to address site-specific biases and assay sensitivity limitations.
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 compared VAMS capillary finger prick samples with venous liquid and venous VAMS samples from 50 healthy volunteers for thiamine diphosphate measurement, finding 94 to 100 per cent of results within 20 per cent of their mean across all comparisons with no significant bias. VAMS microsamples also remained stable when sent through regular post without affecting results, supporting their use for decentralised thiamine status assessment in both developed and remote settings.
Researchers successfully validated an analytical method for measuring creatinine across plasma and volumetric absorptive microsampling devices, demonstrating strong correlation between conventional plasma and dried microsamples. This provides a reliable, patient-centric approach for monitoring kidney function remotely during transplant follow-up.
Untargeted metabolomic profiles from three blood microsampling devices aligned more closely with whole blood than with plasma, and all devices distinguished sex based on amino acids, lipids, and acylcarnitines. This validates that device choice can be tailored to the metabolites of interest for decentralised human biomonitoring.
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.