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Systems pharmacology models are having an increasing impact on pharmaceutical research and development, from preclinical through post-approval phases, including use in regulatory interactions. Given the wide diversity among the models and the contexts of use, a common but flexible strategy for model assessment is needed to enable the appropriate interpretation of model-based results. We present an approach to evaluate these models and discuss how it can be customized to available data and intended application. This article is protected by copyright. All rights reserved.

A Flexible Approach for Context‐Dependent Assessment of Quantitative Systems Pharmacology Models