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Cracking the Code: Unveiling the Trustworthy World of In-Silico Trials

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Manage episode 479542741 series 3608409
Content provided by UK CEiRSI | InSilicoUK. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by UK CEiRSI | InSilicoUK or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.

Are computational models ready to replace traditional clinical trials? This episode delves into the fascinating world of in silico trials and their growing role in regulatory evaluation of biomedical products. We explore a methodological framework based on the ASME VV-40-2018 standard that establishes credibility through verification, validation, and uncertainty quantification. From defining contextual use to conducting thorough risk analysis, we examine how these principles apply across statistical, machine learning, Bayesian, and agent-based models. We compare regulatory approaches between different authorities and make the case for wider adoption of credibility assessment standards to ensure reliable virtual evidence. Join us as we navigate the cutting edge of computational modelling in healthcare regulation.

Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods. 2021 Jan;185:120-127.

  continue reading

33 episodes

Artwork
iconShare
 
Manage episode 479542741 series 3608409
Content provided by UK CEiRSI | InSilicoUK. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by UK CEiRSI | InSilicoUK or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.

Are computational models ready to replace traditional clinical trials? This episode delves into the fascinating world of in silico trials and their growing role in regulatory evaluation of biomedical products. We explore a methodological framework based on the ASME VV-40-2018 standard that establishes credibility through verification, validation, and uncertainty quantification. From defining contextual use to conducting thorough risk analysis, we examine how these principles apply across statistical, machine learning, Bayesian, and agent-based models. We compare regulatory approaches between different authorities and make the case for wider adoption of credibility assessment standards to ensure reliable virtual evidence. Join us as we navigate the cutting edge of computational modelling in healthcare regulation.

Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods. 2021 Jan;185:120-127.

  continue reading

33 episodes

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