Model-informed drug development uses quantitative models and simulations to explore scientific questions and inform decisions throughout development.
Why it matters
Models can help connect available data, physiological knowledge and assumptions. They are particularly useful for exploring scenarios that would be difficult to evaluate experimentally in every combination.
The importance of context
A model should be evaluated against its intended use. The required evidence, qualification strategy and uncertainty analysis vary with the decision being supported.
This is an introductory educational article, not a statement of company experience or regulatory acceptance.
For educational purposes only. Scientific and regulatory conclusions require project-specific assessment.
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