Project description
Environmental risk assessment of medicines
There are nearly 2 000 active pharmaceutical ingredients (APIs) in use, but little is known about the risks they pose to the environment. As a result, there is an urgent need for science-based methods that identify environmental threats earlier in the drug development process. The EU-funded PREMIER project proposes an information and assessment system based on minimum testing that describes the environmental risk of APIs, including relevant human metabolites and environmental transformation products. The system will deliver tailored assessment, identify potential environmental damage and make existing environmental data more accessible for all stakeholders. The project will combine world-leading research on the environmental threats represented by APIs with the principles of co-design and smart knowledge-based IT.
Objective
There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these has been assessed. This calls for pragmatic science-based approaches for prioritising existing APIs in terms of their environmental risk. Such approaches could also be used pro-actively, i.e. to identify environmental concerns earlier in the drug development process, thereby contributing to a more sustainable future. The overall aim of PREMIER is to deliver an API information and assessment system for characterising the potential environmental risks of APIs, including relevant human metabolites and environmental transformation products, based on minimal testing. This system will be designed to screen and prioritise legacy APIs for tailored environmental assessment; identify potential environmental hazards associated with APIs in development; and to make the available environmental data more accessible for all stakeholders. The system will be optimized and validated using case studies on approximately 25 APIs. PREMIER will realize its aim by combining world-leading research on the environmental risks of APIs with
the principles of co-design and smart knowledge-based IT. Through this combination, we want to be more than a conventional research project. We want to ensure that the results of our ground-breaking research “work” address all the societal concerns about the potential risks posed by the presence of pharmaceuticals in the environment.
Fields of science
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
6525 XZ Nijmegen
Netherlands
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Participants (27)
YO10 5DD York North Yorkshire
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65439 Florsheim
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
3721 MA Bilthoven
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20156 Milano
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8600 Dubendorf
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21335 Luneburg
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EX4 4QJ Exeter
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08007 Barcelona
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
YO1 8QG York
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
10717 Berlin
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
80686 Munchen
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00014 Helsingin Yliopisto
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405 30 Goeteborg
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151 85 Sodertaelje
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TW89GS Brentford
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4070 Basel
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51373 Leverkusen
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10154 New York
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4056 Basel
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94250 GENTILLY
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92284 Courbevoie
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RG21 4FA Basingstoke
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1083 HS Amsterdam
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08889 Whitehouse Station Nj
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2340 Beerse
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SL1 3UH Slough
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1197 NYON
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