Cyprotex PLC have today launched an update of their popular Drug-Drug Interaction Regulatory Guidance booklet.
Important new regulatory guidelines for drug-drug interaction (DDI) studies have been released this year. Initially, draft FDA guidance for drug interactions studies were released for comment in February. In June, the European Medicines Agency (EMA) adopted a new guideline on the investigation of drug interactions and this is due to come into effect as of January 2013.
By popular request from our customers, Cyprotex have constructed an easy-to-follow pocket-sized handbook entitled ‘DDI Regulatory Guidance – An easy to follow guide’ which summarises key information from the latest drug interaction guidance documents. It offers a side-by-side comparison of the recommendations from both the FDA and EMA regulatory authorities. The handbook assists in the design and planning of in vitro DDI studies and provides concise information on how the data are used to guide clinical DDI studies.
Commenting on the launch of the handbook, Dr. Anthony Baxter, Chief Executive Officer of Cyprotex, said: “Our DDI handbook provides a valuable resource for scientists who can now access the key information from the regulatory authorities in an easy-to-read format. The handbook also acts as an educational tool for new scientists in the field who are unfamiliar with these guidelines. We have had an overwhelming response to the revised handbook, with over 500 potential customers already pre-ordering the updated version, which will be distributed later this week.”