Modelling and Simulation

Mathematical Modelling and Simulation, or Model Informed Drug Development (MIDD), is a powerful tool to support drug development, regulatory review and investment decisions. Modelling techniques, such as PK/PD, QSP and PopPK can be applied across the drug development continuum, integrating information from diverse data sources to gain deeper insights into drug mechanism of action, predict research outcomes and help inform research decision-making.

The benefits of integrating MIDD into your drug development workflow include:

Improve decision-making and research design

MIDD provides robust, quantitative evidence, that enhances credibility and confidence in the chosen path. For example, providing evidence to support dosing and scheduling in FIH trials, shifting from Maximal Tolerated Dose to the Biological Effective Dose.

Cost and time savings

Through the prediction of research outcomes, the most promising approaches can be prioritised, enabling fewer more targeting experiments, and smaller, more efficient trial designs. MIDD helps avoid redundant research by using existing data and models to inform new research.

Regulatory support

Regulators are increasingly seeing the value of MIDD in providing supporting evidence for efficacy, providing rationale to trail design – including optimised drug dosing, and prediction of drug safety. Agencies such as the FDA and EMA now actively support and encourage the use of such techniques in submissions.

Click examples below to find out more:

Physiomics brings decades of experience providing mathematical modelling and simulation solutions. We therefore understand the importance of working collaboratively with our clients to develop models that best meet their needs. Some examples of our clients and partners can be found here.

 

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