Pharmaceutical Research Associates Group (pra Group)

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	Quelques documents de Pharmaceutical Research Associates Group (pra Group)
	European Union Microdose AMS Partnership Programme EUMAPP 2005 - 2008 Sujets : Biotechnology, Life Sciences, Medicine, Health Type de contrat : Specific Targeted Research Project Participants : EUROPEAN FEDERATION OF PHARMACEUTICAL SCIENCES SVERIGE EUROPEAN FEDERATION OF PHARMACEUTICAL SCIENCES Other EUFEPS SECRETARIAT PO Box 1136 Wallingatan 26 A SVERIGE STICHTING BEOORDELING ETHIEK BIOMEDISCH ONDERZOEK NEDERLAND STICHTING BEOORDELING ETHIEK BIOMEDISCH ONDERZOEK Other PO Box 1004 Noorderstaete 20, 9402 XB NEDERLAND UNIVERSITY OF MANCHESTER UNITED KINGDOM UNIVERSITY OF MANCHESTER Education CENTRE FOR APPLIED PHARMACOKINETIC RESEARCH, SCHOOL OF PHARMACY AND PHARMACEUTICAL SCIENCES Oxford Road UNITED KINGDOM PHARMACEUTICAL RESEARCH INSTITUTE (INSTYTUT FARMACEUTYCZNY) POLSKA PHARMACEUTICAL RESEARCH INSTITUTE (INSTYTUT FARMACEUTYCZNY) Research PRI CHEMISTRY DEPARTMENT Rydygiera 8 POLSKA PHARMACEUTICAL RESEARCH ASSOCIATES GROUP BV (PRA GROUP BV) NEDERLAND PHARMACEUTICAL RESEARCH ASSOCIATES GROUP BV (PRA GROUP BV) Industry CLINICAL FACILITIES PO Box 200 Stationsweg 163 NEDERLAND UNIVERSITY OF LUND SVERIGE UNIVERSITY OF LUND Education DEPARTMENT OF PHYSICS, DIVISION OF NUCLEAR PHYSICS PO Box 118 Sölvegatan 14 SVERIGE ACIES FRANCE ACIES Other EUROPEAN PROJECTS DEPARTMENT 69 rue de la République FRANCE INSTITUT DE RECHERCHES INTERNATIONALES SERVIER France INSTITUT DE RECHERCHES INTERNATIONALES SERVIER Industry IRIS 6 place des Pléiades France PHARMACEUTICAL RESEARCH ASSOCIATES GROUP (PRA GROUP) Netherlands PHARMACEUTICAL RESEARCH ASSOCIATES GROUP (PRA GROUP) Industry CLINICAL FACILITIES PO Box 200 Stationsweg 163 Netherlands CYPROTEX DISCOVERY United Kingdom CYPROTEX DISCOVERY Industry SCIENTIFIC COMPUTING GROUP 13-15 Beech Lane, Cheshire United Kingdom SERVIER RESEARCH & DEVELOPMENT United Kingdom SERVIER RESEARCH & DEVELOPMENT Industry CENTRE FOR BIOPHARMACY RESEARCH Wexham Springs, Framewood Road, Wexham, Gallious United Kingdom XCELERON United Kingdom XCELERON Industry XCELERON LTD York Biocentre, Innovation Way Heslington United Kingdom Hide objective 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. Source : cordis