Objectif
Active pharmaceutical ingredients (APIs) can be released to the natural environment during the manufacturing process, following use by patients or when unused medicines are disposed of. As APIs are biologically active compounds concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 15 years, a substantial amount of work has been done to determine the occurrence, fate, effects, and resulting risks of APIs in the environment and regulatory schemes have been developed requiring environmental risk assessments of all new APIs. However for most APIs currently in use, limited data are available on environmental risks and for new APIs, the testing regimes may not always be optimum. The aim of this project therefore is to develop frameworks that utilise information from toxicological studies, pharmacological mode of action and in silico models to support more intelligent environmental testing of pharmaceuticals in development and to prioritise legacy pharmaceuticals for full environmental risk assessment and/or environmental (bio) monitoring. The aim will be delivered through a number of specific objectives: 1) to review existing approaches for prioritisation and mode of action based intelligent testing of APIs and develop improved frameworks; 2) to establish a high quality database on the properties, environmental fate characteristics and ecotoxicity of APIs; 3) to develop methods for estimating external and internal exposure to APIs for different scenarios; 4) to develop methods and models for predicting ecotoxicological responses to APIs; 5) to validate the developed models, concepts and frameworks using targeted experiments; and 6) to develop a software system to support intelligent testing and prioritisation of APIs in the environment. These objectives will be delivered by a world leading consortium comprising experts in data management and computational modelling, pharmacology, ecotoxicology, environmental chemistry, predictive (eco)toxicology, prioritisation and intelligent testing methodologies and environmental risk assessment.
Champ scientifique
Appel à propositions
IMI-JU-11-2013
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Régime de financement
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinateur
51373 Leverkusen
Allemagne
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Participants (25)
08003 Barcelona
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YO10 5DD York North Yorkshire
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04318 Leipzig
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65439 Florsheim
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6525 XZ Nijmegen
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06844 Dessau-Rosslau
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EX4 4QJ Exeter
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28006 Madrid
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08002 Barcelona
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LS11 5PS Leeds
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90411 Nurnberg
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L3 5UX Liverpool
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10154 New York
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TW89GS Brentford
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2340 Beerse
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RG21 4FA Basingstoke
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08889 Whitehouse Station Nj
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4070 Basel
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151 85 Sodertaelje
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94250 GENTILLY
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CT13 9NJ Sandwich
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4056 Basel
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55218 Ingelheim
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Participation terminée
1019 GM AMSTERDAM
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1019 GM AMSTERDAM
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