The tutorial will be an opportunity to understand better the value of Modelling and Simulation (M&S) / Model Informed Drug Discovery and Development (MID3) in the development of new medicinal products, and the impact of MID3 on regulatory decision making and product labelling.
The tutorial will be divided in three parts.
First, the basic concepts and principles of modelling and simulation will be recalled and the added value over two stage approach will be discussed using examples.
The second part will be dedicated to the use of M&S and MID3 in the context of drug development and the impact it can have in key decision making: study design optimization, data analysis, dose selection and extrapolation will be discussed.
The last part will be dedicated to model evaluation given the purpose. For each of the application of M&S/MID3 in drug development, the relevant criteria for model evaluation will be presented and discussed. Focus will be made on data needed, model assumptions and uncertainties and fitting performances and examples will be provided for good and bad practices. Challenges in current practices (given the current regulatory requirements) will also be discussed.