Steven Erpelinck BSc. MBA
- AMS transporters
- PBPK modeling
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TNO cooperates with companies, the public sector and other organisations, to apply our knowledge and expertise with and for others.
We develop knowledge not for its own sake, but for practical application.
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The enormous innovation that has been realized by TNO, within the field of biomedical accelerator mass spectrometry (AMS), was an ideal topic for discussion during the session ‘Into New Territories-Technology’ at the European Bioanalysis Forum (EBF) held in November 2015 in Barcelona. The EBF brings companies together to discuss about bio-analytical sciences (i.e. procedures, regulatory issues, technological advancements).
Using a microdosing approach, new drugs can be tested in human volunteers, very early during drug development. This requires sensitive analytical techniques, whereby AMS is the most sensitive instrument, allowing quantification at low fg/ml levels.
Whereas AMS used to be a slow, expensive technique, that required significant sample amounts at TNO we revolutionized the approach. TNO operates at the forefront of AMS technology, offering an infrastructure where sample size and time are no longer limiting factors, using an automated CO2 combustion AMS setup.
A microdose or microtracer study in combination with extreme sensitive AMS analysis can 'easily' provide clinical PK data, including mass balance, metabolite profiling and absolute bio-availability. This innovation opens opportunities to drug discovery for improved clinical development plans, saving time, money and animal lives.
We have presented method total 14C count qualification results in small samples volumes of human plasma, blood, urine and homogenized feces. In addition we show excellent dilution linearity between the AMS, low level liquid scintillation counter and liquid scintillation counter. As Phase 0 studies can provide PK data, and any Phase I clinical study can easily become a MIST or MB study.
Many pharmaceutical companies now request for the possibilities to perform a microdosing/tracer study at our site, and we have had several audits recently by large clinical (inter)national CRO’s.
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