RE: Reporting of interim models in Pop PK Reports

From: Mark Sale - Next Level Solutions mark@nextlevelsolns.com Subject: RE: [NMusers] Reporting of interim models in Pop PK Reports Date: Tue, 18 Jul 2006 12:12:39 -0700 Bill, I'm curious where in the guidance you're refering to. It refers to "significant" step - which I interpret as a fairly strong term - seems likely there might be < 20 "significant" steps in an analaysis. The fact that they suggest a "flow diagram" suggests that no one want to wade through 100's of models. The focus seems to be on discussion of the final model, not how you got there. Here is a section under IX. POPULATION PK STUDY REPORT D. Materials and Methods 3. Data Analysis Methods This section should contain a detailed description of the criteria and procedures for model building and reduction, including exploratory data analysis. The following components of the data analysis method used in the study should be described here: (1) the chosen population analysis method, (2) the assumptions on model components (e.g., parameterization, random effects distributions), (3) the rationale underlying those assumptions, and (4) the chosen model-fitting method. In addition, this section should contain a description of the treatment of outliers and missing data (where applicable), as well as a flow diagram(s) (if possible) of the analysis performed and representative control/command files for each significant model building/reduction step. E. Results The key results of the analysis should be compiled in comprehensible tables and plots. Diagnostic plots used to develop the model and test reliability should be included. To aid interpretation and application, a thorough description of the results should be provided. Complete output of results obtained for the final population model and key intermediate steps should be included. Here is a section describing including the final model in an appendix H. Appendix The appendix should contain a representative portion of the data set used in population analysis. The programming codes along with the printouts of the results of the final model should be included, as well as any additional plots that are deemed important (see section Mark Sale MD Next Level Solutions, LLC www.NextLevelSolns.com