another TDM success story: determination of a novel antiepileptic

In the realm of therapeutic drug monitoring, particularly for measuring antiepileptics, microsampling techniques continue to make good on their promise.

Scientists from Unilabs York Bioanalytical Solutions in the United Kingdom and UCB Biopharma in Belgium recently developed, validated, and performed an exciting new approach for determination of a novel antiepileptic drug in dried human blood, based on breakthrough dried blood microsampling techniques – and they’ve shared their remarkable results.

In this study, an analyte solution was spiked into fresh wet blood, mixed and sampled onto multiple Mitra^® microsampler tips. Overnight, the tips dried in a rack, and organic and aqueous extraction processes were put to the test. The organic extraction method showed more promise and was thus picked for further optimization.

The study succeeded in bridging between dried blood microsampling and wet plasma sampling. Regarding the hematocrit bias that has hampered the adoption older dried blood sampling methods, in the case of these Volumetric Absorptive Microsampling (VAMS™) based techniques, "precision and bias were within the validation acceptance criteria" at all HCT levels.

This follows quickly on the heels of a similar success story from Altasciences in Quebec. The success of these studies is a tribute both to the promise and efficacy of VAMS techniques and to the scientific diligence of the researchers making it work. Their diligence will pave the way for even easier success for others in the future.

Since 2016, there has been exponential growth in interest in the use of microsampling techniques, particularly within the context of clinical drug development. Microsampling techniques eliminate many technical and logistical concerns formerly associated with the use of dried blood. Their advantages over traditional venipuncture are clear; they allow for remote blood collection (anywhere, anytime, by nearly anyone, with minimal training), and can be part of a less stressful sampling experience, especially for children and the elderly.

It’s hardly surprising to see VAMS gain more widespread interest with therapeutic drug monitoring, validation, and adoption by the month. The bold and diligent scientists and clinicians who believe in microsampling suggest that this will only continue.