Run Record for Model Development
The EMA and FDA (link not working) recommend including a run record in your technical report to describe any major decisions and should include an overview of the steps taken during model development. KIWI 1.3, available in May 2015, will reduce the time taken to perform this task to just minutes.
By a click of a button, KIWI will select flagged NONMEM runs or all runs within a project or stage of a project and output to an excel file information from your runs that are needed for the run record table recommended by the agencies. A sampling of information that is output from KIWI includes: run name, who ran the model, flags associated with the model, number of subjects, number of observations, objective function, parameter estimates, and data file used. Parameter estimates can be easily compared across runs. Data files used for all runs are listed to provide a double check that a wrong data file wasn’t inadvertently used. This information can be customized to a standard format within excel and easily ported into your technical report error-free.
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For KIWI licensing information or a KIWI demonstration, call us at +1 716.633.3463 or send us a note! (link to form)