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WP6

It is the aim of all developments within WP6 to provide new tools to facilitate Model-Based Drug Development (MBDD) in the pharmaceutical industry. Indeed, demands for MBDD go beyond the facilitation of interactions between existing software tools.

The demands include:

  • The building of mechanistic models that combine existing knowledge on the disease and the project level with new data from a recent experiment or study. New methodologies for parameter estimation in complex models will be developed.
  • The initial focus is on complex models for diabetes. Specific plans include: visual diagnostics for time-to-event models, guidance for model building with correlated covariates, and new types of normalised prediction distribution errors.
  • The simulation of future experiments or studies in order to support development decisions that lead to an optimal portfolio management. A second prototype of a Clinical Trial Simulator has been distributed for testing to interested EFPIA participants in the work package.
  • The optimal design of future experiments or studies. These are not just designs that increase the probability of success, but designs that deliver results within a reasonable timeframe and within a predefined budget.

Each of the four tasks within WP6 addresses one of these four demands. The specific challenges of WP6 are:

  • To develop new tools that will fit into a framework that itself is evolving during the lifespan of DDMoRe.
  • To develop new tools which meet the expectations of the customers, i.e. the EFPIA members in the consortium.
  • To develop new tools not from scratch but from existing tools which are already in use among the customers.
  • To find a balance between what is doable within the budget of DDMoRe and what is expected by the customer.

 

 

  • News posted on 6 years 5 months ago

    Current Use and Developments Needed for Optimal Design in Pharmacometrics: A Study Performed Among DDMoRe’s European Federation of Pharmaceutical Industries and Associations Members. F Mentré, M... Read more

  • Project posted on 6 years 9 months ago

    Animation: Introduction to PK modelling generated for Education and Training DDMoRe Conception: Elena Carvajal & Marc Lavielle Execution: Elena Carvajal Scientific Coordinator: Marc Lavielle... Read more

  • Nov 09 to Nov 11, 2011
    United Kingdom
    Events posted on 7 years 11 months ago

    November 9 - 11, UK Presentation on first prototype Clinical Trial Simulator for DDMoRe by Marc Lavielle, INRIA

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