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

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

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...

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Detalles Bibliográficos
Otros Autores: Viceconti, Marco. editor (editor), Emili, Luca. editor
Formato: Libro electrónico
Idioma:Inglés
Publicado: Cham : Springer Nature Switzerland 2024.
Edición:1st ed. 2024.
Colección:Synthesis Lectures on Biomedical Engineering,
Materias:
Biomedical engineering.
Bioethics.
Computer simulation.
Biomedical Engineering and Bioengineering.
Computer Modelling.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009805100106719
Tabla de Contenidos:
  • Introduction
  • Theoretical foundations of Good Simulation Practice
  • Model development
  • Model credibility
  • Possible regulatory pathways
  • Possible Health Technology Assessment pathways
  • Ethical review of in silico methodologies
  • The sponsor
  • The investigator: modellers and analysts.

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