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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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Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Viceconti, Marco (Editor), Emili, Luca (Editor)
Format: eBook
Language:English
Published: Cham : Springer Nature Switzerland : Imprint: Springer, 2024.
Edition:1st ed. 2024.
Series:Synthesis Lectures on Biomedical Engineering,
Subjects:
Biomedical engineering.
Bioethics.
Computer simulation.
Biomedical Engineering and Bioengineering.
Computer Modelling.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • 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.