1.

Record Nr.

UNINA9910842096403321

Titolo

Toward Good Simulation Practice : Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products / / edited by Marco Viceconti, Luca Emili

Pubbl/distr/stampa

Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2024

ISBN

9783031482847

3031482840

Edizione

[1st ed. 2024.]

Descrizione fisica

1 online resource (X, 144 p. 19 illus., 12 illus. in color.)

Collana

Synthesis Lectures on Biomedical Engineering, , 1930-0336

Disciplina

610.28

Soggetti

Biomedical engineering

Bioethics

Computer simulation

Biomedical Engineering and Bioengineering

Computer Modelling

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di contenuto

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.

Sommario/riassunto

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. This book is open access, which means that you have free and unlimited access. Offers readers a unique guide to In Silico Trials Documents consensus process run by the most authoritative organizations worldwide in the field Represents the first



attempt to produce a consensus position on the best practice for In Silico Trials.