InSilicoTrials is thrilled to announce the publication of โ๐๐ค๐ฌ๐๐ง๐ ๐๐ค๐คd ๐๐๐ข๐ช๐ก๐๐ฉ๐๐ค๐ฃ ๐๐ง๐๐๐ฉ๐๐๐ โ Best practices for the use of computational modelling & simulation in the regulatory process of biomedical products โ a crucial document guiding the use of simulation data & evidence in the regulatory process of biomedical products.
This work is the culmination of a global collaboration among in silico experts, coordinated by the In Silico World consortium, with significant contributions from the Avicenna Alliance, VPH Institute, and FDA professionals.
Published in open access by Springer Nature Group, the book is edited by Prof. Marco Viceconti and InSilicoTrialsโ CEO Luca Emili, addressing the need for standardized practices within the in silico field.
Our strong belief is anchored in the insightful foreword by Pras Pathmanathan from the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health at the FDA, suggesting a future where these words manifest into reality โโฆ ๐ช๐ต ๐ช๐ด ๐ฉ๐ฐ๐ฑ๐ฆ๐ฅ ๐ต๐ฉ๐ข๐ต ๐ต๐ฉ๐ช๐ด ๐ฃ๐ฐ๐ฐ๐ฌ ๐ธ๐ช๐ญ๐ญ ๐ด๐ต๐ช๐ฎ๐ถ๐ญ๐ข๐ต๐ฆ ๐ง๐ถ๐ณ๐ต๐ฉ๐ฆ๐ณ ๐ค๐ฐ๐ฏ๐ท๐ฆ๐ณ๐ด๐ข๐ต๐ช๐ฐ๐ฏ๐ด ๐ข๐ฎ๐ฐ๐ฏ๐จ๐ด๐ต ๐ข๐ญ๐ญ ๐ด๐ต๐ข๐ฌ๐ฆ๐ฉ๐ฐ๐ญ๐ฅ๐ฆ๐ณ๐ด ๐ข๐ฏ๐ฅ ๐ถ๐ญ๐ต๐ช๐ฎ๐ข๐ต๐ฆ๐ญ๐บ ๐ค๐ฐ๐ฏ๐ต๐ณ๐ช๐ฃ๐ถ๐ต๐ฆ ๐ต๐ฐ ๐ต๐ฉ๐ฆ ๐ฅ๐ฆ๐ท๐ฆ๐ญ๐ฐ๐ฑ๐ฎ๐ฆ๐ฏ๐ต ๐ฐ๐ง ๐ค๐ฐ๐ฎ๐ฎ๐ถ๐ฏ๐ช๐ต๐บโ๐ข๐ค๐ค๐ฆ๐ฑ๐ต๐ฆ๐ฅ ๐๐ฐ๐ฐ๐ฅ ๐๐ช๐ฎ๐ถ๐ญ๐ข๐ต๐ช๐ฐ๐ฏ ๐๐ณ๐ข๐ค๐ต๐ช๐ค๐ฆ, ๐ฃ๐ณ๐ช๐ฏ๐จ๐ช๐ฏ๐จ ๐&๐ ๐ง๐ฐ๐ณ ๐ฎ๐ฆ๐ฅ๐ช๐ค๐ข๐ญ ๐ฑ๐ณ๐ฐ๐ฅ๐ถ๐ค๐ต๐ด ๐ต๐ฐ ๐ฎ๐ข๐ต๐ถ๐ณ๐ช๐ต๐บ.โ
Please find below the bookโs index and an overview of the chaptersโ content:
- Introduction
- Theoretical Foundations of GSP
- Model Development
- Model Credibility
- Possible Qualification Pathways for In Silico Methodologies
- Possible Health Technology Assessment Pathways
- Ethical Review of In Silico Methodologies
- The Sponsor
- The Investigator: modellers and analysts
Link to freely download the book: https://link.springer.com/book/10.1007/978-3-031-48284-7
If youโre seeking more details or interested in exploring how this groundbreaking publication can enhance your biosimulation strategies, donโt hesitate to get in touch. Our InSilicoTrials experts are ready to assist you in understanding the implications of Good Simulation Practice (GSP) for your projects, illustrating best practices, and demonstrating use cases to maximize GSPโs benefits for your drug development endeavors.