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In the model qualification step, simulated P1NP and CTX were consistent with changes in the turnover markers from three clinical trials with romosozumab and two clinical trials with blosozumab (Supplementary Figure 3).
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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.
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.
Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation (World Health Organization).
Second, complex discussions related to product labeling have dragged out the pre-qualification step far longer than ever anticipated.
The model time step is 1/3 hours.
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