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In the process of bringing drug candidates and new food ingredients to the market, companies are urgently looking for ways to improve the efficiency of their development process. Microdosing, a technique that involves testing small amounts of products in humans at a very early stage in the development process, may be part of the answer. However, the technique has yet to be applied on a large scale.
TNO is conducting on-site research using an Accelerator Mass Spectrometer (AMS), a tool that supports microdosing studies in humans. This state-of-the-art technology will generate human kinetic data on drug candidates and innovative food ingredients earlier than is currently possible. This will significantly reduce the need for animal testing prior to clinical phases. It also supports TNO’s aim to reduce the cost and duration of drug and food development. TNO is the first organisation in continental Europe to offer these innovative AMS services to pharma, biotech and innovative food companies.
Customers will gain the advantages of outsourcing microdosing, toxicological and analytical research to one external partner – TNO. The integrated services, microdosing, toxicological and analytical research, will improve the translational aspects of customers’ preclinical development programs.
In microdosing, human volunteers are given a 14C-labeled bioactive ingredient in such a minute dose to keep potential risks to a minimum. Blood is sampled from volunteers at specific time intervals. Scientists then analyse the samples using the AMS. Since the AMS can detect trace amounts of 14C, concentrations of the bioactive and its metabolites are determined and used to obtain the absorption, metabolism and excretion rates. This information is essential for companies to determine the further development of candidate drugs or food ingredients. Thus, microdosing will allow companies to focus their clinical development programmes on those candidates with the most suitable kinetic profile in humans.