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Pharmacometrics at FDA
Guidances
Guidances
Model/Data Format
The following are the general expectations for submitting pharmacometric data and models:
All datasets used for model development and validation should be submitted as a SAS transport files (*.xpt). A description of each data item should be provided in a Define.pdf file. Any concentrations and/or subjects that have been excluded from the analysis should be flagged and maintained in the datasets.
Model codes or control streams and output listings should be provided for all major model building steps, e.g., base structural model, covariates models, final model, and validation model. These files should be submitted as ASCII text files with *.txt extension (e.g.: myfile_ctl.txt, myfile_out.txt).
A model development decision tree and/or table which gives an overview of modeling steps.
For the population analysis reports we request that you submit, in addition to the standard model diagnostic plots, individual plots for a representative number of subjects. Each individual plot should include observed concentrations, the individual predication line and the population prediction line. In the report, tables should include model parameter names and units. For example, oral clearance should be presented as CL/F (L/h) and not as THETA(1). Also provide in the summary of the report a description of the clinical application of modeling results.
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Date created: November 19, 2008 |
