Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products

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Springer Nature Switzerland (2024)
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Abstract

In this open access book, the Community of Practice led by the VPH Institute, the Avicenna Alliance, and the In Silico World consortium has brought together 138 experts in In Silico Trials working in academia, the medical industry, regulatory bodies, hospitals, and consulting firms. Through a consensus process, these experts produced the first attempt to define some Good Simulation Practices on how to develop, evaluate, and use In Silico Trials. Good Simulation Practice constitutes an indispensable guide for anyone who is planning to engage at any title with In Silico Trials.

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9783031482830   9783031482847   3031482867   3031482832

DOI

10.1007/978-3-031-48284-7
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Introduction.  (pages 1-8)Marco Viceconti, Liesbet Geris, Luca Emili, Axel Loewe, Bernard Staumont, Enrique Morales-Orcajo, Marc Horner, Martha De Cunha Maluf-Burgman & Raphaëlle Lesage
Theoretical Foundations of Good Simulation Practice.  (pages 9-23)Marco Viceconti, Miguel Juárez, Axel Loewe, Daniela Calvetti, Erkki Somersalo, Liesbet Geris, Marc Horner & Martha De Cunha Maluf-Burgman
Model Development.  (pages 25-42)Alexander Kulesza, Axel Loewe, Andrea Stenti, Chiara Nicolò, Enrique Morales-Orcajo, Eulalie Courcelles, Fianne Sips, Francesco Pappalardo, Giulia Russo, Marc Horner, Marco Viceconti, Martha De Cunha Maluf-Burgman, Raphaëlle Lesage & Steve Kreuzer
Model Credibility.  (pages 43-66)Eulalie Courcelles, Marc Horner, Payman Afshari, Alexander Kulesza, Cristina Curreli, Cristina Vaghi, Enrique Morales-Orcajo, Francesco Pappalardo, Ghislain Maquer, Giulia Russo, Liesbet Geris, Marco Viceconti, Michael Neidlin, Philippe Favre, Raphaëlle Lesage, Steve Kreuzer & Vincenzo Carbone
Possible Qualification Pathways for In Silico Methodologies.  (pages 67-72)Marco Viceconti, Alexandre Serigado, Cécile F. Rousseau & Emmanuelle M. Voisin
Possible Health Technology Assessment Pathways.  (pages 73-92)Mireia Espallargues Carreras, Xavier Garcia Cuscó, Rossana Alessandrello, Ramon Maspons, Alexandre Serigado, Cécile F. Rousseau, Emmanuelle M. Voisin, Enrique Morales-Orcajo & Marco Viceconti
Ethical Review of In Silico Methodologies.  (pages 93-100)Cécile F. Rousseau, Emmanuelle M. Voisin, Elisabetta Poluzzi, Alexandre Serigado, Marco Viceconti & Maria Cristina Jori
The Sponsor.  (pages 101-113)Maria Cristina Jori, Roberta Bursi & Marco Viceconti
The Investigator: Modellers and Analysts.  (pages 115-122)Raphaëlle Lesage, Axel Loewe, Enrique Morales-Orcajo & Marco Viceconti

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Ethical Review of In Silico Methodologies.Cécile F. Rousseau, Emmanuelle M. Voisin, Elisabetta Poluzzi, Alexandre Serigado, Marco Viceconti & Maria Cristina Jori - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 93-100.
Introduction.Marco Viceconti, Liesbet Geris, Luca Emili, Axel Loewe, Bernard Staumont, Enrique Morales-Orcajo, Marc Horner, Martha De Cunha Maluf-Burgman & Raphaëlle Lesage - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 1-8.
The Sponsor.Maria Cristina Jori, Roberta Bursi & Marco Viceconti - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 101-113.
Theoretical Foundations of Good Simulation Practice.Marco Viceconti, Miguel Juárez, Axel Loewe, Daniela Calvetti, Erkki Somersalo, Liesbet Geris, Marc Horner & Martha De Cunha Maluf-Burgman - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 9-23.
The Investigator: Modellers and Analysts.Raphaëlle Lesage, Axel Loewe, Enrique Morales-Orcajo & Marco Viceconti - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 115-122.
Possible Health Technology Assessment Pathways.Mireia Espallargues Carreras, Xavier Garcia Cuscó, Rossana Alessandrello, Ramon Maspons, Alexandre Serigado, Cécile F. Rousseau, Emmanuelle M. Voisin, Enrique Morales-Orcajo & Marco Viceconti - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 73-92.
Possible Qualification Pathways for In Silico Methodologies.Marco Viceconti, Alexandre Serigado, Cécile F. Rousseau & Emmanuelle M. Voisin - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 67-72.
Model Development.Alexander Kulesza, Axel Loewe, Andrea Stenti, Chiara Nicolò, Enrique Morales-Orcajo, Eulalie Courcelles, Fianne Sips, Francesco Pappalardo, Giulia Russo, Marc Horner, Marco Viceconti, Martha De Cunha Maluf-Burgman, Raphaëlle Lesage & Steve Kreuzer - forthcoming - Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products:25-42.
Model Credibility.Eulalie Courcelles, Marc Horner, Payman Afshari, Alexander Kulesza, Cristina Curreli, Cristina Vaghi, Enrique Morales-Orcajo, Francesco Pappalardo, Ghislain Maquer, Giulia Russo, Liesbet Geris, Marco Viceconti, Michael Neidlin, Philippe Favre, Raphaëlle Lesage, Steve Kreuzer & Vincenzo Carbone - 2024 - In Marco Viceconti & Luca Emili (eds.), Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products. Springer Nature Switzerland. pp. 43-66.
Beyond the dichotomy in vivo - in vitro: In silico.Pio Garcia - unknown

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