Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.
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| Title: | Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility. |
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| Authors: | Musuamba FT; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Federal Agency for Medicines and Health Products, Brussels, Belgium.; Faculté des Sciences Pharmaceutiques, Université de Lubumbashi, Lubumbashi, Congo., Skottheim Rusten I; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Norvegian Medicines Agency, Oslo, Norway., Lesage R; Biomechanics Section, KU Leuven, Leuven, Belgium.; Virtual Physiological Human Institute, Leuven, Belgium., Russo G; Department of Drug and Health Sciences, University of Catania, Catania, Italy., Bursi R; InSilicoTrials Technologies, Milano, Italy., Emili L; InSilicoTrials Technologies, Milano, Italy., Wangorsch G; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany., Manolis E; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; European Medicines Agency, Amsterdam, The Netherlands., Karlsson KE; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Swedish Medical Products Agency, Uppsala, Sweden., Kulesza A; Novadiscovery, Lyon, France., Courcelles E; Novadiscovery, Lyon, France., Boissel JP; Novadiscovery, Lyon, France., Rousseau CF; Voisin Consulting Life Sciences, Boulogne (Paris), France., Voisin EM; Voisin Consulting Life Sciences, Boulogne (Paris), France., Alessandrello R; AQuAS - Agency for Health Quality and Assessment of Catalonia, Catalonia, Spain., Curado N; Exploristics, Belfast, UK., Dall'ara E; Insigneo Institute, Sheffield University, Sheffield, UK., Rodriguez B; Department of Computer Science, British Heart Foundation Centre of Research Excellence, University of Oxford, Oxford, UK., Pappalardo F; Department of Drug and Health Sciences, University of Catania, Catania, Italy., Geris L; Biomechanics Section, KU Leuven, Leuven, Belgium.; Virtual Physiological Human Institute, Leuven, Belgium.; GIGA In silico Medicine, Université de Liège, Liège, Belgium. |
| Source: | CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 804-825. Date of Electronic Publication: 2021 Jul 13. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't |
| Journal Info: | Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 2163-8306 |
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| DOI: | 10.1002/psp4.12669 |