Currently, DDIs account for 3-5 percent of all reported adverse drug reactions in hospitals, and this is only growing as patients today are being prescribed more drugs(1). The DDIRC helps drug developers predict DDIs with greater confidence and make more informed drug safety decisions, much earlier in the drug development process. The 2.0 release has advanced in-product visualization and filters supporting the quick identification of DDI risk. These visualizations are built upon a more comprehensive dataset for more reliable results. The updated tool also improves the ease of submitting dossiers to the FDA and other international medicines agencies.
"Predicting potential drug-drug interaction is a key component of risk management at all stages of clinical development and throughout the drug lifecycle," says Eric Didier, Head of PKPD Department at Pierre Fabre. "Through our cooperation with Elsevier, we believe DDIRC is the perfect tool for addressing this important topic in the most precise and time effective manner, with great visual outputs and complete trackability of input sources."
The DDIRC provides calculations and predictions in a transparent, explainable way, removing the black box around equations using mechanistic static modeling, replicating the physiological processes occurring in the body. The tool enables researchers to track predictions through the development cycle from pre-clinical to phase 3 trials and project manage multiple simulations at the same time. It also assists with inclusion and exclusion criteria for patients in phase 2 and 3 trials to improve safety.
Thibault Géoui, Senior Director Discovery Biology and Predictive Risk Management, Elsevier commented: "In the past, DDIs have been difficult to identify as they were not found in the clinical development process - as patients taking other medicines are often excluded from clinical trials. They are then only discovered when patients experience adverse events in real life situations. However, by using the DDIRC in the drug development process, potential DDIs can be discovered early and adverse reactions in patients post-market can be prevented."
The predictive power of PharmaPendium's DDIRC enables researchers to compare their valuable internal data with external data including public regulatory filings to understand the extent of drug reactions. The DDIRC has been developed in line with the FDA's guidelines for prediction of enzyme-mediated DDI risk to make dossier submissions as straightforward as possible. PharmaPendium's DDIRC 2.0 is now available.
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1. Sourced from: “Preventable Adverse Drug Reactions: A Focus on Drug Interactions.” Silver Spring, MD, USA. © United States Food and Drug Administration, 2018.