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DDI regulatory guidance, an easy to follow guide
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DDI regulatory guide

 
 

A new European Medicines Agency (EMA) guideline on the investigation of drug interactions (DDI) has recently been adopted and came into effect in January 2013. A new draft US FDA guidance on drug interactions studies (DDI) was released for comment in February 2012.

 
By popular request from our clients, Cyprotex have assembled an easy-to-follow guide which summarizes the key information from both of these guidance documents. The guide provides a side-by-side comparison of the recommendations from the US and European regulatory authorities which is useful when planning study design. It focuses predominantly on in vitro assessment of DDI.
 
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on 16th April 2014
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