PharmPK Discussion - Reporting of interim models in Pop PK Reports

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On 18 Jul 2006 at 10:00:23, "Bonate, Peter" (Peter.Bonate.-a-.genzyme.com) sent the message


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.-at-.genzyme.com
phone: 210-949-8662
fax: 210-949-8219

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