Objectif
The concept of human microdosing with a view to obtaining critical pharmacokinetic (PK) information to assist in the development of new drugs is a relatively new approach. As the pharmaceutical industry is a relatively conservative one, the potential value of this technology has been recognised by many but taken on board by few. It is therefore imperative that a body of knowledge is built to convince the pharmaceutical industry of the merits of human microdosing as a science driven approach to drug development. Standardised, well defined, ultra-sensitive and easy to use technologies for enabling human microdosing are required to facilitate the adoption of the microdosing concept and hence accelerate the drug development process. The European Union Microdose AMS Partnership Programme (EUMAPP) project gathers together 10 organisations from 5 countries (United Kingdom, Sweden, Netherlands, France and Poland) towards the certification of high and low voltage ultra-sensitive Accelerator Mass Spectrometry (AMS) technologies as the most accurate, reproducible and appropriate analytical methodologies for all measurements required by microdosing studies. Microdosing approach conducted with AMS offers new ways of developing drugs that allow bridging the present gap between the laboratory and the clinic. The EUMAPP project will contribute to putting Europe at the forefront of microdosing by i) demonstrating the microdosing approach reliabilityfor predicting drugs PK when used at pharmacological doses (from 7 different biopharmaceuticals), ii) certifying AMS as the most accurate, appropriate and powerful technology for reproducible measurements required by microdosing studies, and finally iii) developing in silico modelling application to predict PK parameters from data derived from microdosing studies. Overall, EUMAPP provides a tremendous opportunity for Europe to gain leadership in the microdosing field and avoid being left behind worldwide competitors.
Champ scientifique
Appel à propositions
FP6-2004-LIFESCIHEALTH-5
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Régime de financement
STREP - Specific Targeted Research ProjectCoordinateur
YORK
Royaume-Uni