Assessment of low volume sampling technologies: utility in nonclinical and clinical studies
Williams et al.
The finding, in our words
Two feasibility studies assessed low-volume blood sampling for therapeutic drug monitoring. In patients receiving an anti-A therapeutic, drug levels were measured from finger-prick whole blood collected with Neoteryx Mitra and from capillary plasma collected with TASSO OnDemand, and compared with venipuncture samples. The work outlines practical considerations for adopting these patient-centric microsampling methods in decentralised trials and clinical care.
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 ↗
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.
Mandlekar et al., Clinical pharmacology and therapeutics (paywalled) · source ↗
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
Maass et al., Clinical and Translational Science · source ↗
In ten healthy volunteers, radiprodil pharmacokinetics measured by Aqua-Cap™ Drummond microsampling closely matched conventional venous blood draws, whereas Mitra™ microsampling gave marginally lower exposure values. Both microsampling methods fell within the accepted bioequivalence range, indicating they could enable patient-centric therapeutic drug monitoring and future paediatric decentralised trials.
Sciberras et al., Pharmacology research & perspectives · source ↗