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7/13/09 Outcomes from EUMAPP - A study comparing in vitro, in silico, microdose and pharmacological dose pharmacokinetics
Date Posted: |
13 Jul 2009 |
Summary: |
The European Microdosing AMS Partnership Programme (EUMAPP), funded by the European Union, was a major international, multi-centre research study involving collaboration between industry and academia.
The objectives of EUMAPP were:
• To assess if there was pharmacokinetic linearity following a microdose and a therapeutic dose for 7 drugs representative of situations where traditional pharmacokinetic predictive models (eg in vitro and animal species) are problematic.
• To compare the accuracy of the pharmacokinetic predictions made by microdosing to those made from physiologically based pharmacokinetic (PB-PK) computer models.
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For all of the drugs tested in EUMAPP, Intravenous microdose data predicted t1/2, CL and V very well. Oral dose data did not scale as well as the IV dose but in general, the data obtained would have been useful in the selection of drug candidates for further development (or dropped from the development pipeline).
Where oral microdose data did not scale so well, the reasons can all be surmised from the known metabolic or chemical properties of the drug and therefore add to our understanding of the utility of microdosing.
EUMAPP has contributed to our knowledge of microdosing and has added to our understanding of where this technique can be best applied to drug selection.
Please follow this link to read more and download the final EUMAPP project outcomes.
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