Model-informed drug development (MIDD) is a process aimed at accelerating drug development, advancing regulatory science, and delivering benefits to patients. As defined by the latest FDA guidance, the MIDD paradigm involves utilising various quantitative methods to strike a balance between the risks and benefits of drug products in development.
To enable the successful application of MIDD approaches, various quantitative tools are utilised, such as population PK/PD (POP PK/PD), Exposure-Response (E-R), Longitudinal disease modelling, Physiologically-based Pharmacokinetics (PBPK), Model-based Meta-analysis (MBMA) & Quantitative System Pharmacology (QSP).
These tools allow for the integration of data from multiple sources and the development of comprehensive models that can inform drug development decisions.
Successful implementation of MIDD approaches can lead to improved clinical trial efficiency, higher chances of regulatory approval, and optimal drug dosing and individualisation without the need for dedicated trials.
MBPharmaco Consulting offers specialised support in Model-Informed Drug Development (MIDD) through the utilisation of computational techniques. By leveraging our expertise in MIDD, we can help streamline your drug development program and optimise dosing strategies for improved clinical outcomes.
Contact us to learn more about how our services can benefit your organisation.