Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products

This open-access book, brought together by the VPH Institute, Avicenna Alliance, and In Silico World consortium, defines Good Simulation Practices for developing, evaluating, and using In Silico Trials, providing a valuable guide for stakeholders.

Format: Paperback / softback
Length: 144 pages
Publication date: 23 February 2024
Publisher: Springer International Publishing AG

This open-access book, brought together by the VPH Institute, the Avicenna Alliance, and the In Silico World consortium, has united 138 esteemed experts in In Silico Trials from academia, the medical industry, regulatory bodies, hospitals, and consulting firms. Through a collaborative process, these experts have crafted the first comprehensive attempt to define Good Simulation Practices, providing valuable insights on how to develop, evaluate, and utilize In Silico Trials effectively.

Good Simulation Practice serves as an essential resource for individuals seeking to delve into the realm of In Silico Trials. It offers a comprehensive framework that encompasses the key aspects and considerations necessary for successful implementation of these trials. By drawing upon the expertise and collective wisdom of these esteemed experts, the book provides a valuable roadmap for researchers, practitioners, policymakers, and stakeholders involved in the field.

The book is organized into five chapters, each dedicated to a specific aspect of Good Simulation Practice. The first chapter provides an introduction to In Silico Trials, defining their scope, objectives, and potential applications. It also highlights the importance of simulation in drug development and the need for robust simulation methodologies.

Chapter two delves into the development of simulation models, emphasizing the importance of accurate and validated models that can accurately represent the biological processes and interactions involved in drug development. It discusses the various modeling techniques, such as computational modeling, experimental modeling, and hybrid modeling, and highlights the significance of selecting the appropriate modeling approach based on the specific research question and available data.

Chapter three explores the evaluation of simulation models, emphasizing the need for rigorous and reproducible evaluation methodologies. It discusses the various evaluation criteria, such as validity, reliability, and uncertainty, and highlights the importance of using appropriate statistical methods and tools to assess the performance of simulation models.

Chapter four focuses on the use of simulation in drug discovery and development, emphasizing the importance of integrating simulation into the drug discovery process early on. It discusses the various applications of simulation, such as virtual screening, lead optimization, and drug repositioning, and highlights the potential benefits of using simulation in reducing the cost and time of drug development.

Chapter five concludes the book by discussing the challenges and opportunities associated with the use of simulation in drug development. It highlights the need for interdisciplinary collaboration, regulatory guidance, and standardized methodologies to ensure the safe and effective use of simulation in drug development.

In summary, Good Simulation Practice is a groundbreaking work that provides a comprehensive and authoritative guide to Good Simulation Practices in In Silico Trials. It is an indispensable resource for researchers, practitioners, policymakers, and stakeholders interested in advancing the field of drug development and improving patient outcomes. By leveraging the expertise and insights of these esteemed experts, the book offers valuable guidance on how to develop, evaluate, and utilize In Silico Trials effectively, paving the way for a more efficient and effective drug discovery process.

Dimension: 240 x 168 (mm)
ISBN-13: 9783031482861