Obiettivo
The OrBiTo project will deliver novel methods and a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This will be achieved through novel propsective studies to define new methodlogies which will be validated using historical datasets from EFPIA partners. A combination of high quality in vitro or in silico characterizations of API and formulations will be integrated into physiologically based in silico models capturing the full complexity of oral drug absorption. This approach will drive model based pharmaceutical product development in accordance with visions of Quality by Design. Benefits include an accelerated formulation development process, particularly for challenging projects e.g. for low solubility molecules or modified-release formulations as well as allowing optimization of clinical product performance for patient benefit. In addition, it will significantly reduce the need for future animal experiments in this area and reduce the need for human bioequivalence studies for bridging between formulations within clinical programmes. The consortium is composed of world-leading scientists in a unique multidisciplinary collaboration where competences from nine academic partners, one regulatory agency, one non-profit research organisation and three SMEs are brought together with the twelve EFPIA partners giving an unparalleled opportunity to deliver transformational change in European industrial product development.
Campo scientifico
Invito a presentare proposte
IMI-JU-04-2011
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Meccanismo di finanziamento
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinatore
151 85 Sodertaelje
Svezia
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Partecipanti (26)
751 05 Uppsala
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M13 9PL Manchester
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17489 Greifswald
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10561 Athina
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2595 DA Den Haag
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EC2Y 5EB London
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75103 Uppsala
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RH18 5DW FOREST ROW
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55122 Mainz
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60323 Frankfurt Am Main
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G1 1XQ Glasgow
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1165 Kobenhavn
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3000 Leuven
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65205 Wiesbaden
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51373 Leverkusen
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55218 Ingelheim
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TW89GS Brentford
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2340 Beerse
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2500 Valby
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08889 Whitehouse Station Nj
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4056 Basel
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02200 Espoo
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CT13 9NJ Sandwich
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94250 GENTILLY
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93534 Lancaster
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10154 New York
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