With Model-Informed Drug Development (MIDD) existing data can be leveraged to provide important insights on product safety and effectiveness, offering the benefit of more streamlined drug development. Modeling and simulation can help inform decisions that increase the probability of success in clinical studies and reduce the cost of drug development overall. The FDA and EMA have both acknowledged that modeling and simulation is an essential component across all drug development programs involving new molecular entities.
MIDD is useful at any stage of development but is most beneficial when it is integrated early and continuously to help guide program objectives and to make critical decisions. MIDD has the potential to help save large amounts of time, money, and other resources by supporting key program decisions and predicting the likelihood of a drug’s success.
The MIDD paradigm as defined by the most recent FDA guidance states, “MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development. When successfully applied, MIDD approaches can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials.”
It has never been more important to consider utilizing computational MIDD techniques as part of your drug development program. Learn how Allucent can help streamline your drug development program with our Model Informed Dose & Drug Development services including: