MBDD - Model Based Drug Development

Model-based drug development (MBDD) can be thought of as a series of learn-predict-confirm cycles, which integrate two or more of the six components represented in the diagram (outer ring of hexagons). Clinical trial simulation techniques can be used to integrate models, designs and decision criteria to enhance the quantitative and rational development of drugs. Evaluating the predictive performance of the models and updating of the models as new data emerge is essential to the successful implementation of an MBDD strategy. For examples employing these MBDD concepts see Lalonde, Kowalski, Hutmacher, et al., CPT 2008.