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

Abstract The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this...

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Autores principales:	Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall’ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/97e2e67f5a5b4314bf9e9f73a5497dde
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spelling	oai:doaj.org-article:97e2e67f5a5b4314bf9e9f73a5497dde2021-11-19T15:35:29ZScientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility2163-830610.1002/psp4.12669https://doaj.org/article/97e2e67f5a5b4314bf9e9f73a5497dde2021-08-01T00:00:00Zhttps://doi.org/10.1002/psp4.12669https://doaj.org/toc/2163-8306Abstract The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this white paper, we propose a risk‐informed evaluation framework for mechanistic model credibility evaluation. To properly frame the proposed verification and validation activities, concepts such as context of use, regulatory impact and risk‐based analysis are discussed. To ensure common understanding between all stakeholders, an overview is provided of relevant in silico terminology used throughout this paper. To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick‐start tool by regulators. Altogether, this white paper provides a practical approach to model evaluation, applicable in both scientific and regulatory evaluation contexts.Flora T. MusuambaIne Skottheim RustenRaphaëlle LesageGiulia RussoRoberta BursiLuca EmiliGaby WangorschEfthymios ManolisKristin E. KarlssonAlexander KuleszaEulalie CourcellesJean‐Pierre BoisselCécile F. RousseauEmmanuelle M. VoisinRossana AlessandrelloNuno CuradoEnrico Dall’araBlanca RodriguezFrancesco PappalardoLiesbet GerisWileyarticleTherapeutics. PharmacologyRM1-950ENCPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 8, Pp 804-825 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950
spellingShingle	Therapeutics. Pharmacology RM1-950 Flora T. Musuamba Ine Skottheim Rusten Raphaëlle Lesage Giulia Russo Roberta Bursi Luca Emili Gaby Wangorsch Efthymios Manolis Kristin E. Karlsson Alexander Kulesza Eulalie Courcelles Jean‐Pierre Boissel Cécile F. Rousseau Emmanuelle M. Voisin Rossana Alessandrello Nuno Curado Enrico Dall’ara Blanca Rodriguez Francesco Pappalardo Liesbet Geris Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
description	Abstract The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this white paper, we propose a risk‐informed evaluation framework for mechanistic model credibility evaluation. To properly frame the proposed verification and validation activities, concepts such as context of use, regulatory impact and risk‐based analysis are discussed. To ensure common understanding between all stakeholders, an overview is provided of relevant in silico terminology used throughout this paper. To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick‐start tool by regulators. Altogether, this white paper provides a practical approach to model evaluation, applicable in both scientific and regulatory evaluation contexts.
format	article
author	Flora T. Musuamba Ine Skottheim Rusten Raphaëlle Lesage Giulia Russo Roberta Bursi Luca Emili Gaby Wangorsch Efthymios Manolis Kristin E. Karlsson Alexander Kulesza Eulalie Courcelles Jean‐Pierre Boissel Cécile F. Rousseau Emmanuelle M. Voisin Rossana Alessandrello Nuno Curado Enrico Dall’ara Blanca Rodriguez Francesco Pappalardo Liesbet Geris
author_facet	Flora T. Musuamba Ine Skottheim Rusten Raphaëlle Lesage Giulia Russo Roberta Bursi Luca Emili Gaby Wangorsch Efthymios Manolis Kristin E. Karlsson Alexander Kulesza Eulalie Courcelles Jean‐Pierre Boissel Cécile F. Rousseau Emmanuelle M. Voisin Rossana Alessandrello Nuno Curado Enrico Dall’ara Blanca Rodriguez Francesco Pappalardo Liesbet Geris
author_sort	Flora T. Musuamba
title	Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
title_short	Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
title_full	Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
title_fullStr	Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
title_full_unstemmed	Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
title_sort	scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: building model credibility
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/97e2e67f5a5b4314bf9e9f73a5497dde
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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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