Reporting of interim models in Pop PK Reports

From: "Bonate, Peter" Peter.Bonate@genzyme.com Subject: [NMusers] Reporting of interim models in Pop PK Reports Date: Tue, 18 Jul 2006 10:00:23 -0400 I was just reading the new CHMP guidance on Pop PK Reports. The guidance recommends including the final structural and covariate model from NONMEM (control stream and listing) as an appendix. It makes no mention of interim models. So this got me thinking (which can be a bad thing in itself) that in my current pop pk reports, I include every model referenced in the report during model development. Granted this leads to reports that are 1000s of pages long, but every number in the text can be verified by a QC person. So this got me asking myself, what do other companies do? If you don't include the nonmem listing as an appendix and in your text you state that the OFV was X, then how do you reference that number? I'm just curious what others are doing these days? Thanks, pete bonate Peter L. Bonate, PhD Genzyme Corporation Senior Director, Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA peter.bonate@genzyme.com phone: 210-949-8662 fax: 210-949-8219