Miniaturised Extraction Techniques in Personalised Medicine: Analytical Opportunities and Translational Perspectives.

Miniaturised sampling and extraction are redefining therapeutic drug monitoring (TDM) by enabling low-volume sampling, simplifying collection, and improving patient acceptability, while also promoting decentralised workflows and more sustainable laboratory practices. This review critically appraises the current landscape, with emphasis on analytical performance, matrix compatibility, and readiness for clinical implementation. It examines validation requirements, the extent of alignment and existing gaps across major regulatory guidelines, and recurrent challenges such as haematocrit bias, real-world stability and transport, incurred sample reanalysis, device variability, commutability with conventional matrices, and inter-laboratory reproducibility. To make the evidence actionable, operational recommendations are distilled into a practical ten-point checklist designed to support validation and translation of miniaturised approaches into routine laboratory practice. Looking ahead, priorities include automation and portable platforms, advanced functional materials, and integration with digital tools and biosensors, alongside the development of harmonised frameworks tailored to miniaturised methods and prospective clinical studies that demonstrate impact on dosing decisions, adherence, and clinical outcomes. Overall, this review aims to equip researchers, laboratory professionals, and regulators with the knowledge to implement miniaturised bioanalysis and advance personalised medicine through TDM.