Reducing adverse event risk with informed, data-driven decisions about DDIs
Predicting the risk of drug interactions to guide decisions about which drugs to prioritize or eliminate
Drug-drug interactions (DDIs) account for 3-5% of all reported adverse drug reactions. And their incidence is increasing, primarily because patients are being prescribed more drugs, meaning the likelihood of taking a combination of drugs is higher.
In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that
pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development, as part of an adequate assessment of the drug’s safety and effectiveness.
Identifying potential DDIs and assessing their risk is a priority for pharmaceutical manufacturers and regulatory authorities. Assessments should be performed as early as possible in development to minimize health risks to clinical trial subjects and patients who may already be on a medication, and to prevent considerable spending on a drug that will fail during the most expensive stage of development, reach the market with severe prescribing restrictions, be subject to a costly recall or be a source of adverse events.
The Drug-Drug Interaction Risk Calculator (DDIRC) in PharmaPendium is fully compliant with the FDA’s 2012 draft guidance for drug interaction studies.
As a mechanistic static model calculator, the DDRIC can be used early in drug development, before anything is known about the elimination routes of the victim compound or the role of gut extraction for the victim and/or inhibitor in humans. It also provides important insight in later stages of development when these parameters are already known.
Thanks to clear visual output data, the DDIRC makes it easy to see drugs with high risk of interaction, even when hundreds of drugs are under consideration.
"The results provided by DDIRC are easier to work with than those from base DDI prediction models." — Senior Scientist,
Global Biopharmaceutical Group
The advantage with the DDIRC is its type of result.
The results provided by DDIRC are easier to work with than those from base DDI prediction models, which require very little input data to predict DDIs but can predict a long list of prohibited drugs. That may over-complicate clinical trials.
The Drug-Drug Interaction Risk Calculator provides unique and actionable insights into the behavior of drugs in humans. In all applications at this global biopharmaceutical group, it has helped to inform decisions that have saved the company time, money and resources, and most importantly, have reduced the risk of adverse events caused by drug-drug interactions.
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