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

      Model Credibility

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          Abstract

          The need for a framework to justify that a model has sufficient credibility to be used as a basis for internal or external (typically regulatory) decision-making is a primary concern when using modelling and simulation (M&S) in healthcare. This chapter reviews published standards on verification, validation, and uncertainty quantification (VVUQ) as well as regulatory guidance that can be used to establish model credibility in this context, providing a potential starting point for a globally harmonised model credibility framework.

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          In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products

          Highlights • Regulators now consider also evidences produced in silico. • We need accepted methods to evaluate the credibility of models. • In this paper we describe the use of the ASME V&V-40 technical standard. • We also discuss its application to various types of modelling methods.
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            A comprehensive framework for verification, validation, and uncertainty quantification in scientific computing

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              Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

              The use of computational models in drug development has grown during the past decade. These model‐informed drug development (MIDD) approaches can inform a variety of drug development and regulatory decisions. When used for regulatory decision making, it is important to establish that the model is credible for its intended use. Currently, there is no consensus on how to establish and assess model credibility, including the selection of appropriate verification and validation activities. In this article, we apply a risk‐informed credibility assessment framework to physiologically‐based pharmacokinetic modeling and simulation and hypothesize this evidentiary framework may also be useful for evaluating other MIDD approaches. We seek to stimulate a scientific discussion around this framework as a potential starting point for uniform assessment of model credibility across MIDD. Ultimately, an overarching framework may help to standardize regulatory evaluation across therapeutic products (i.e., drugs and medical devices).
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                Author and book information

                Book Chapter
                2024
                February 23 2024
                : 43-66
                10.1007/978-3-031-48284-7_4
                9ea79e27-0544-4811-8915-1c463152d32c
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