A new European Medicines Agency (EMA) guideline on the investigation of drug interactions (DDI) has recently been adopted and will be coming in to 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 summarises 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.
Please fill in the form below to receive your printed copy of our DDI guide.