2025 · Clinical Pharmacology in Drug Development · open access
At-Home Self-Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open-Label Feasibility Trial
Raoufinia et al.
The finding, in our words
A phase 1 trial designed around participant self-collection of pharmacokinetic samples at home, with video training and pre-assembled kits: evidence that the model is a training and logistics package, not only a device.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
When patiromer is taken three hours after tacrolimus, it does not alter tacrolimus exposure in kidney transplant recipients. The study also shows that self-collected capillary blood samples using volumetric absorptive microsampling (VAMS) can reliably measure tacrolimus concentrations, which simplifies pharmacokinetic studies and enables decentralised therapeutic drug monitoring.
This review found that volumetric microsampling devices, such as Mitra, HemaPEN, HemaXis DB10, and Tasso-M20, overcome haematocrit bias, whilst Telimmune plasma separation cards enable direct plasma collection without centrifugation. These technologies support patient-centric, decentralised sampling, though the authors note that clinical validation remains limited across different drugs and patient populations.
The study determined that using self-collected dried blood spots alongside online surveys was a feasible and acceptable method for remote pre-exposure prophylaxis adherence monitoring, with 64% of participants returning at least one blood specimen.
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.