Modeling & simulation (M&S) tools have long been used in engineering and aerospace industries to develop products that would be prohibitively expensive to optimize through iterative improvement of prototypes. Modern drug development is now adapting and integrating analogous tools based on information from all phases of the development process since it is neither cost-effective nor time-efficient to tackle all open questions experimentally. As a result, an increasing number of decisions are now based on M&S at various levels of physiological and temporal complexity. However, prospective identification of clinically relevant sources of variability remain a challenge. To overcome this challenge the integrated use of multidisciplinary research approaches is needed.
The objective of this webinar is to provide selected case examples that highlight the added value of integrated use of real-world outcomes-, pharmacometric, and physiologically based pharmacokinetic approaches for identifying clinically-relevant sources of variability and translating them into actionable items.