Good Simulation Practice
Good Simulation Practice require in silico medicine to become less speculative, and increasingly translational, that is to say, immediately applicable and useful for clinical and industrial applications.
The book ð§ðžððŪðŋðą ððžðžðą ðĶðķðšððđðŪððķðžðŧ ðĢðŋðŪð°ððķð°ðē Published Open Access on Springer NatureÂ
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InSilicoTrials is thrilled to announce the publication of “ððĪðŽðð§ð ððĪðĪd ðððĒðŠðĄððĐððĪðĢ ðð§ðððĐððð – 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.Â
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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.Â
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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.Â
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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 “âĶ ðŠðĩ ðŠðī ðĐð°ðąðĶðĨ ðĩðĐðĒðĩ ðĩðĐðŠðī ðĢð°ð°ðŽ ðļðŠðð ðīðĩðŠðŪðķððĒðĩðĶ ð§ðķðģðĩðĐðĶðģ ðĪð°ðŊð·ðĶðģðīðĒðĩðŠð°ðŊðī ðĒðŪð°ðŊðĻðīðĩ ðĒðð ðīðĩðĒðŽðĶðĐð°ððĨðĶðģðī ðĒðŊðĨ ðķððĩðŠðŪðĒðĩðĶððš ðĪð°ðŊðĩðģðŠðĢðķðĩðĶ ðĩð° ðĩðĐðĶ ðĨðĶð·ðĶðð°ðąðŪðĶðŊðĩ ð°ð§ ðĪð°ðŪðŪðķðŊðŠðĩðš–ðĒðĪðĪðĶðąðĩðĶðĨ ðð°ð°ðĨ ððŠðŪðķððĒðĩðŠð°ðŊ ððģðĒðĪðĩðŠðĪðĶ, ðĢðģðŠðŊðĻðŠðŊðĻ ð&ð ð§ð°ðģ ðŪðĶðĨðŠðĪðĒð ðąðģð°ðĨðķðĪðĩðī ðĩð° ðŪðĒðĩðķðģðŠðĩðš.”Â
Chapters’ content:Â
- IntroductionÂ
- Theoretical Foundations of GSPÂ
- Model DevelopmentÂ
- Model CredibilityÂ
- Possible Qualification Pathways for In Silico MethodologiesÂ
- Possible Health Technology Assessment PathwaysÂ
- Ethical Review of In Silico MethodologiesÂ
- The SponsorÂ
- The Investigator: modellers and analystsÂ
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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.