QSP modelling - at the heart of the action.
Nelleke Snelder Senior Consultant LAP&P Consultants BV Leiden, The Netherlands
PKPD modelling has developed from an empirical and descriptive approach into a scientific discipline based on the (patho-) physiological mechanisms behind PKPD relationships. As a result, PKPD models range from purely empirical models, i.e. descriptive models to mechanism-based and Quantitative Systems Pharmacology (QSP) models with an increasing level of complexity and increasing level of predictive power. The preferred PK/PD modelling approach (, i.e. fit-for-purpose modelling) highly depends on the questions that need to be answered in addition to what level of detail is required. Empirical and mechanism-based models have already demonstrated their value in drug-development and examples of the application of QSP models are emerging. Application of QSP models, however, may be challenging as they are more complex and require a larger amount of informative data. Moreover, combining different types of information is essential for QSP approaches. The questions for the modeller at hand are: (1) what knowledge is required to answer the question, (2) how to select and integrate informative data, (3) how to balance between complexity and quantifiability and (4) when am I happy to stop? These questions, as well as the potential to recycle the developed systems model for other purposes, will be addressed during this webinar using the development of a systems pharmacology model for the cardiovascular effects of S1P agonists as an example.