The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches in drug development.
The roadmap, developed by the recently formed ICH MIDD Discussion Group, lays out the harmonization body’s vision for an MIDD general principles guideline, additional MIDD-specific guidelines, and incorporating MIDD-principles and approaches into several of its existing guidelines. (RELATED: ICH MIDD concept paper coming by years-end, Regulatory Focus 20 May 2021)
The goal of MIDD is to make drug development more efficient by integrating data from mathematical and statistical models in predicting a drug’s effects and reducing unnecessary patient exposure….
