Clinical and Pre-Clinical Application
on DBS

The pre-clinical and clinical market summarizes the testing of new pharmaceuticals in animal (pre-clinical) and human (clinical) studies. The main advantage in pre-clinical studies is the reduced number of test animals (due to the need for lower blood volumes) which is in accordance with the 3R requirement of animal studies (replacement, reduction, refinement) [1]. Drugs can be studied on a single mouse over several time points, whereas several mice are required with conventional methods. In clinical studies, there is an ease in sampling and more patient comfort.

The pre-clinical and clinical market summarizes the testing of new pharmaceuticals in animal (pre-clinical) and human (clinical) studies. The main advantage in pre-clinical studies is the reduced number of test animals (due to the need for lower blood volumes) which is in accordance with the 3R requirement of animal studies (replacement, reduction, refinement) [1]. Drugs can be studied on a single mouse over several time points, whereas several mice are required with conventional methods. In clinical studies, there is an ease in sampling and more patient comfort.

The DBS technology offers huge advantages here, however has not been fully accepted by regulatory bodies so far [2]. The major reason for this is the hematocrit effect based on different blood viscosity. If a sub-punch is taken and the hematocrit value and the volume is unknown, an analytical error may result. However, this only results in a significant error if the hematocrit value is outside of the normal range (40 to 54% for men and 36 to 48% for women [3]) of a healthy patient. Also, in most clinical studies the patient hematocrit value is known.