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As a second level of model qualification, we tested the sensitivity of the system-specific parameters for both models (EPIC 1 and EPIC 2).
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Details of the flight model qualification test program are presented.
Model qualification.
JM created the methotrexate population pharmacokinetic model, provided model qualification and created the forecasting algorithm.
A schematic overview of the model qualification is provided in Figure 5.
The level of model qualification is dependent on the question being addressed.
The objective of model qualification is to examine whether the model is suitable for the proposed applications.
This approach is not different from an earlier proposed general model qualification method to ensure that physiological models are fit for purpose.
For plasma PK profiles and urinary metabolite ratios, model qualification was performed by comparing population mean or individual values of the observations with the model predictions.
In the recently proposed framework for model qualification of physiological models, the first step frames the project questions and the project team agrees on the use of the model inferences for the decision making.
Model qualification was performed by comparing clinically measured SLD with those predicted by the model, evaluating the uncertainty in parameter values, and using the model to perform a simulation of two sets of 10,000 virtual patients.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com