Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

Author:

Musuamba Flora T.123ORCID,Skottheim Rusten Ine14ORCID,Lesage Raphaëlle56,Russo Giulia7,Bursi Roberta8,Emili Luca8,Wangorsch Gaby19,Manolis Efthymios110,Karlsson Kristin E.111ORCID,Kulesza Alexander12,Courcelles Eulalie12,Boissel Jean‐Pierre12,Rousseau Cécile F.13,Voisin Emmanuelle M.13ORCID,Alessandrello Rossana14,Curado Nuno15,Dall’ara Enrico16,Rodriguez Blanca17ORCID,Pappalardo Francesco7ORCID,Geris Liesbet5618

Affiliation:

1. EMA Modelling and Simulation Working Party Amsterdam The Netherlands

2. Federal Agency for Medicines and Health Products Brussels Belgium

3. Faculté des Sciences Pharmaceutiques Université de Lubumbashi Lubumbashi Congo

4. Norvegian Medicines Agency Oslo Norway

5. Biomechanics Section KU Leuven Leuven Belgium

6. Virtual Physiological Human Institute Leuven Belgium

7. Department of Drug and Health Sciences University of Catania Catania Italy

8. InSilicoTrials Technologies Milano Italy

9. Paul‐Ehrlich‐Institut (Federal Institute for Vaccines and Biomedicines) Langen Germany

10. European Medicines Agency Amsterdam The Netherlands

11. Swedish Medical Products Agency Uppsala Sweden

12. Novadiscovery Lyon France

13. Voisin Consulting Life Sciences Boulogne (Paris) France

14. AQuAS ‐ Agency for Health Quality and Assessment of Catalonia Catalonia Spain

15. Exploristics Belfast UK

16. Insigneo Institute Sheffield University Sheffield UK

17. Department of Computer Science British Heart Foundation Centre of Research Excellence University of Oxford Oxford UK

18. GIGA In silico Medicine Université de Liège Liège Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

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