The book 𝗧𝗼𝘄𝗮𝗿𝗱 𝗚𝗼𝗼𝗱 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲 Published Open Access on Springer Nature

InSilicoTrials is thrilled to announce the publication of “𝙏𝙤𝙬𝙖𝙧𝙙 𝙂𝙤𝙤d 𝙎𝙞𝙢𝙪𝙡𝙖𝙩𝙞𝙤𝙣 𝙋𝙧𝙖𝙘𝙩𝙞𝙘𝙚 – Best practices for the use of computational modelling & simulation in the regulatory process of biomedical products ” 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 InSilicoTrials’ 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 “… 𝘪𝘵 𝘪𝘴 𝘩𝘰𝘱𝘦𝘥 𝘵𝘩𝘢𝘵 𝘵𝘩𝘪𝘴 𝘣𝘰𝘰𝘬 𝘸𝘪𝘭𝘭 𝘴𝘵𝘪𝘮𝘶𝘭𝘢𝘵𝘦 𝘧𝘶𝘳𝘵𝘩𝘦𝘳 𝘤𝘰𝘯𝘷𝘦𝘳𝘴𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘮𝘰𝘯𝘨𝘴𝘵 𝘢𝘭𝘭 𝘴𝘵𝘢𝘬𝘦𝘩𝘰𝘭𝘥𝘦𝘳𝘴 𝘢𝘯𝘥 𝘶𝘭𝘵𝘪𝘮𝘢𝘵𝘦𝘭𝘺 𝘤𝘰𝘯𝘵𝘳𝘪𝘣𝘶𝘵𝘦 𝘵𝘰 𝘵𝘩𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 𝘰𝘧 𝘤𝘰𝘮𝘮𝘶𝘯𝘪𝘵𝘺–𝘢𝘤𝘤𝘦𝘱𝘵𝘦𝘥 𝘎𝘰𝘰𝘥 𝘚𝘪𝘮𝘶𝘭𝘢𝘵𝘪𝘰𝘯 𝘗𝘳𝘢𝘤𝘵𝘪𝘤𝘦, 𝘣𝘳𝘪𝘯𝘨𝘪𝘯𝘨 𝘔&𝘚 𝘧𝘰𝘳 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘵𝘰 𝘮𝘢𝘵𝘶𝘳𝘪𝘵𝘺.” 

Please find below the book’s index and an overview of the chapters’ content: 

1. Introduction 
2. Theoretical Foundations of GSP 
3. Model Development 
4. Model Credibility 
5. Possible Qualification Pathways for In Silico Methodologies 
6. Possible Health Technology Assessment Pathways 
7. Ethical Review of In Silico Methodologies 
8. The Sponsor 
9. The Investigator: modellers and analysts
    

Link to freely download the book: https://link.springer.com/book/10.1007/978-3-031-48284-7 

If you’re seeking more details or interested in exploring how this groundbreaking publication can enhance your biosimulation strategies, don’t 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 GSP’s benefits for your drug development endeavors.