[NMusers] sample size issue

Recently in an interaction with the FDA they asked us to power a
pharmacokinetic study to a given precision in a parameter estimate based
on a pop pk model in a population we have no experience with. In other
words, they wanted us to power a study to ensure that the standard error
of the population mean clearance was less than 30% CV. Does anyone know
how to do this a priori? Does this seem to be something new?
 
Thanks,
 
pete bonate
 
Peter L. Bonate, PhD, FCP
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
crackberry: 210-315-2713
 

Received on Wed Aug 29 2007 - 11:28:58 EDT