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3 projets européens trouvés

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 TERMINÉ 

Oral biopharmaceutics tools (ORBITO)

Date du début: 1 oct. 2012, Date de fin: 30 sept. 2017,

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 ...
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 TERMINÉ 

Incorporating real-life clinical data into drug development (GETREAL)

Date du début: 1 oct. 2013, Date de fin: 31 déc. 2016,

When a new medicine reaches the market, it is accompanied by an extensive data package that provides information about the safety and efficacy of the medicine in a clinical trial setting. However, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA ...
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 32

 TERMINÉ 

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED)

Date du début: 1 oct. 2009, Date de fin: 30 sept. 2015,

RationaleThe inability of pre-clinical studies to predict clinical efficacy is a major bottleneck in drug development. In severe asthma this bottleneck results from: a lack of useful and validated biomarkers, underperforming pre-clinical models, inadequate and incomplete sub-phenotyping, and insufficient disease understanding.HypothesisThe use of biomarker profiles comprised of various types of hi ...
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