Model Credibility

Synthesis lectures on biomedical engineering, pp. 43–66

Abstract

Abstract The need for a framework to justify that a model has sufficient credibility to be used as a basis for internal or external (typically regulatory) decision-making is a primary concern when using modelling and simulation (M&S) in healthcare. This chapter reviews published standards on verification, validation, and uncertainty quantification (VVUQ) as well as regulatory guidance that can be used to establish model credibility in this context, providing a potential starting point for a globally harmonised model credibility framework.

Authors 17

1. Eulalie Courcelles corresponding
   Affiliation as printed

   Novadiscovery, Lyon, France

2. Marc Horner
   Affiliation as printed

   Ansys Inc., Evanston, IL, USA

3. Payman Afshari

   Johnson & Johnson (United States)

   Affiliation as printed

   DePuy Synthes, Johnson & Johnson, Raynham, MA, USA

4. Alexander Jan Kulesza
   Affiliation as printed

   Novadiscovery, Lyon, France

5. Cristina Curreli

   University of Bologna

   Affiliation as printed

   Alma Mater Studiorum—University of Bologna, Bologna, Italy

6. Cristina Vaghi
   Affiliation as printed

   InSilicoTrials Technologies, Trieste, Italy

7. Enrique Morales Orcajo
   Affiliation as printed

   Ambu, Augsburg, Germany

8. Francesco Pappalardo

   University of Catania

   Affiliation as printed

   University of Catania, Catania, Italy

9. Ghislain Maquer

   Zimmer Biomet (Switzerland)

   Affiliation as printed

   Zimmer Biomet, Winterthur, Switzerland

10. Giulia Lo Russo

    University of Catania

    Affiliation as printed

    University of Catania, Catania, Italy

11. Liesbet Geris

    KU Leuven · University of Liège

    Affiliation as printed

    University of Liège, KU Leuven and VPH Institute, Leuven, Belgium

12. Marco Viceconti

    University of Bologna

    Affiliation as printed

    Alma Mater Studiorum—University of Bologna, Bologna, Italy

13. Michael Neidlin Aachen

    RWTH Aachen University

    Affiliation as printed

    RWTH Aachen University, Aachen, Germany

14. Philippe Favre

    Zimmer Biomet (Switzerland)

    Affiliation as printed

    Zimmer Biomet, Winterthur, Switzerland

15. R Lesage
    Affiliation as printed

    VPH Institute, Leuven, Belgium

16. Steven M. Kreuzer

    Exponent (United States)

    Affiliation as printed

    Exponent, Boston, MA, USA

17. Vincenzo Ilario Carbone
    Affiliation as printed

    InSilicoTrials Technologies, Trieste, Italy