sample size issue

From: Peter Bonate Date: August 29, 2007 technical Source: mail-archive.com
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 [EMAIL PROTECTED] phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713

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Aug 29, 2007 Peter Bonate sample size issue
Aug 29, 2007 Marc Gastonguay Re: sample size issue
Aug 29, 2007 Murad Melhem Re: sample size issue
Aug 30, 2007 Bo Jin RE: sample size issue
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