Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility-Reference-Cited by-同舟云学术

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

Published:2021-07-13 Issue:8 Volume:10 Page:804-825
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Musuamba Flora T.¹²³^ORCID,Skottheim Rusten Ine¹⁴^ORCID,Lesage Raphaëlle⁵⁶,Russo Giulia⁷,Bursi Roberta⁸,Emili Luca⁸,Wangorsch Gaby¹⁹,Manolis Efthymios¹¹⁰,Karlsson Kristin E.¹¹¹^ORCID,Kulesza Alexander¹²,Courcelles Eulalie¹²,Boissel Jean‐Pierre¹²,Rousseau Cécile F.¹³,Voisin Emmanuelle M.¹³^ORCID,Alessandrello Rossana¹⁴,Curado Nuno¹⁵,Dall’ara Enrico¹⁶,Rodriguez Blanca¹⁷^ORCID,Pappalardo Francesco⁷^ORCID,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