RE: Reporting of interim models in Pop PK Reports

From: David Dai david.dai@bms.com Subject: RE: [NMusers] Reporting of interim models in Pop PK Reports Date: Tue, 18 Jul 2006 12:09:05 -0400 I practice simlarly to Peter. The main body of my last report is few hundred pages. All important interim model runs are listed in separate tables. The purpose is to show agency the logic line of model building and they can follow it better than only final model is provided. Most models tested will then be listed in the appendix to support main report. The big hassle of writing report like this is the appendix ended up with > 1000 pages. It also increases workload for QC scientist who has to check every number in the main report as well as appendix. What's agency acceptance for a much condensed report? any hint and tips? david -- David Dai, PhD Mail stop: E14-07 Clinical Discovery Bristol-Myers Squibb Company Lawrenceville, NJ 08543 Phone:(609)2526342 Fax:(609)2527821