LEADER 03269nam 22006135 450 001 9910842096403321 005 20241120175050.0 010 $a9783031482847 010 $a3031482840 024 7 $a10.1007/978-3-031-48284-7 035 $a(CKB)30597552500041 035 $a(DE-He213)978-3-031-48284-7 035 $a(MiAaPQ)EBC31727443 035 $a(Au-PeEL)EBL31727443 035 $a(OCoLC)1424862284 035 $a(EXLCZ)9930597552500041 100 $a20240222d2024 u| 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aToward Good Simulation Practice $eBest Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products /$fedited by Marco Viceconti, Luca Emili 205 $a1st ed. 2024. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2024. 215 $a1 online resource (X, 144 p. 19 illus., 12 illus. in color.) 225 1 $aSynthesis Lectures on Biomedical Engineering,$x1930-0336 311 08$a9783031482830 311 08$a3031482832 327 $aIntroduction -- 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. 330 $aThis open access book, the Community of Practice led by the VPH Institute, the Avicenna Alliance, and the In Silico World consortium has brought together 138 experts in In Silico Trials working in academia, the medical industry, regulatory bodies, hospitals, and consulting firms. Through a consensus process, these experts produced the first attempt to define some Good Simulation Practices on how to develop, evaluate, and use In Silico Trials. Good Simulation Practice constitutes an indispensable guide for anyone who is planning to engage at any title with In Silico Trials. This book is open access, which means that you have free and unlimited access. Offers readers a unique guide to In Silico Trials Documents consensus process run by the most authoritative organizations worldwide in the field Represents the first attempt to produce a consensus position on the best practice for In Silico Trials. 410 0$aSynthesis Lectures on Biomedical Engineering,$x1930-0336 606 $aBiomedical engineering 606 $aBioethics 606 $aComputer simulation 606 $aBiomedical Engineering and Bioengineering 606 $aBioethics 606 $aComputer Modelling 615 0$aBiomedical engineering. 615 0$aBioethics. 615 0$aComputer simulation. 615 14$aBiomedical Engineering and Bioengineering. 615 24$aBioethics. 615 24$aComputer Modelling. 676 $a610.28 702 $aViceconti$b Marco$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aEmili$b Luca$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910842096403321 996 $aToward Good Simulation Practice$94146875 997 $aUNINA