
This comprehensive review examines the critical processes of verification, validation, and uncertainty quantification within the context of ecological and biophysical modeling, specifically focusing on their relevance to biomedical research and pharmaceutical development. The article establishes a foundational distinction between verification, which checks the internal mathematical and computational correctness of a model, and validation, which assesses its external accuracy and real-world applicability. To bridge the gap between these processes, the text introduces the evaludation framework, an iterative approach that integrates continuous assessment throughout the entire model development lifecycle. A central component of the discussion is the Context of Use, a defining statement that dictates the specific role, scope, and boundaries of a model. This concept is operationalized through the ASME V&V-40 standard, which employs a risk-informed credibility assessment framework. By evaluating model influence and decision consequence, this standard helps researchers determine the appropriate level of validation rigor required for specific applications. The article also explores the philosophical underpinnings of validation, contrasting data-driven positivist approaches with usefulness-focused relativist perspectives, and advocates for a pragmatic synthesis. Practical challenges in model development are addressed, including the mitigation of missing data through advanced imputation methods like K-Nearest Neighbors and Random Forest, as well as strategies for managing deep parameter uncertainty via sensitivity analysis and Bayesian inference. Furthermore, the text provides a detailed comparative analysis of regulatory validation frameworks from the United States Food and Drug Administration and the European Medicines Agency. While both agencies prioritize patient safety and product quality, they exhibit distinct structural and documentation expectations. By synthesizing these diverse methodologies, standards, and regulatory requirements, the article equips scientists and drug development professionals with the essential tools and protocols needed to build robust, credible, and globally compliant computational models. Source: https://www.ecologysci.com/posts/verification-and-validation-of-ecological-models-techniques-for-credible-predictions-in-biomedical-research
Context of Use, Biomedical Research, ASME V&V-40, ASME V&V-40, Validation, Verification, Uncertainty Quantification, Evaludation, Ecological Models
Context of Use, Biomedical Research, ASME V&V-40, ASME V&V-40, Validation, Verification, Uncertainty Quantification, Evaludation, Ecological Models
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