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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.
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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  Data: Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.
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  Data: <searchLink fieldCode="AU" term="%22Musuamba+FT%22">Musuamba FT</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Skottheim+Rusten+I%22">Skottheim Rusten I</searchLink>; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Norvegian Medicines Agency, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Lesage+R%22">Lesage R</searchLink>; Biomechanics Section, KU Leuven, Leuven, Belgium.; Virtual Physiological Human Institute, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Russo+G%22">Russo G</searchLink>; Department of Drug and Health Sciences, University of Catania, Catania, Italy.<br /><searchLink fieldCode="AU" term="%22Bursi+R%22">Bursi R</searchLink>; InSilicoTrials Technologies, Milano, Italy.<br /><searchLink fieldCode="AU" term="%22Emili+L%22">Emili L</searchLink>; InSilicoTrials Technologies, Milano, Italy.<br /><searchLink fieldCode="AU" term="%22Wangorsch+G%22">Wangorsch G</searchLink>; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany.<br /><searchLink fieldCode="AU" term="%22Manolis+E%22">Manolis E</searchLink>; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; European Medicines Agency, Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Karlsson+KE%22">Karlsson KE</searchLink>; EMA Modelling and Simulation Working Party, Amsterdam, The Netherlands.; Swedish Medical Products Agency, Uppsala, Sweden.<br /><searchLink fieldCode="AU" term="%22Kulesza+A%22">Kulesza A</searchLink>; Novadiscovery, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Courcelles+E%22">Courcelles E</searchLink>; Novadiscovery, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Boissel+JP%22">Boissel JP</searchLink>; Novadiscovery, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Rousseau+CF%22">Rousseau CF</searchLink>; Voisin Consulting Life Sciences, Boulogne (Paris), France.<br /><searchLink fieldCode="AU" term="%22Voisin+EM%22">Voisin EM</searchLink>; Voisin Consulting Life Sciences, Boulogne (Paris), France.<br /><searchLink fieldCode="AU" term="%22Alessandrello+R%22">Alessandrello R</searchLink>; AQuAS - Agency for Health Quality and Assessment of Catalonia, Catalonia, Spain.<br /><searchLink fieldCode="AU" term="%22Curado+N%22">Curado N</searchLink>; Exploristics, Belfast, UK.<br /><searchLink fieldCode="AU" term="%22Dall'ara+E%22">Dall'ara E</searchLink>; Insigneo Institute, Sheffield University, Sheffield, UK.<br /><searchLink fieldCode="AU" term="%22Rodriguez+B%22">Rodriguez B</searchLink>; Department of Computer Science, British Heart Foundation Centre of Research Excellence, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Pappalardo+F%22">Pappalardo F</searchLink>; Department of Drug and Health Sciences, University of Catania, Catania, Italy.<br /><searchLink fieldCode="AU" term="%22Geris+L%22">Geris L</searchLink>; Biomechanics Section, KU Leuven, Leuven, Belgium.; Virtual Physiological Human Institute, Leuven, Belgium.; GIGA In silico Medicine, Université de Liège, Liège, Belgium.
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  Data: <searchLink fieldCode="JN" term="%22101580011%22">CPT: pharmacometrics & systems pharmacology</searchLink> [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 804-825. <i>Date of Electronic Publication: </i>2021 Jul 13.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101580011 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2163-8306 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221638306%22">21638306 </searchLink><i>NLM ISO Abbreviation: </i>CPT Pharmacometrics Syst Pharmacol <i>Subsets: </i>MEDLINE
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