Sentence examples for model qualification using from inspiring English sources
The FDA reviewers' recommendation, based on their independent model qualification using phase I data and subsequent simulations representative of the registration trial, was that "the dose regimen should be further optimized to address the safety concerns for hypercalciuria".
We assessed the highest educational qualification using the two questions from the Census [ 8].
Print an application and determine qualification using the Internet.
Model qualification was conducted using standard nonparametric bootstrap (n = 1,000) and visual predictive check to evaluate the precision of model parameter estimates and robustness of the final PK and efficacy models.
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.
CoSMoS, the principled design framework used in the development of ARTIMMUS, for example, shares many key features with the methods for physiological model qualification in drug discovery proposed by Friedrich and Savic.
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.
The three main companies providing PBPK software used in clinical pharmacology regulatory submissions to date (GastroPlus, PK-Sim, and SimCYP) provided short summaries of their approach to system model qualification.
Details of the flight model qualification test program are presented.
JM created the methotrexate population pharmacokinetic model, provided model qualification and created the forecasting algorithm.
