The European Medicines Agency (EMA) guideline on the investigation of drug interactions (DDI) came into effect in January 2013. The final US FDA guidance on in vitro drug interactions studies (DDI) was released in January 2020.
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.
Please fill in the form below to receive your printed copy of our DDI guide.