Application of PopPK in Drug Development

Perhaps the area where PopPK has made the largest impact is in drug development. Prior to the introduction of NONMEM as a commercial software package, there was little one could do with pharmacokinetic data collected from Phase 3 clinical studies beyond, perhaps, summary statistics and correlations between some summary measure of the pharmacokinetic data, like the mean or median concentration in a subject, and subject 

An example of how PopPK analyses are reported in the product label can be found in the product label for Xeloda (capecitabine), which is manufactured by Hoff-man-La Roche  

The label clearly states that what follows are from the results of a PopPK analysis, what was the sample size, and what were the results from the analysis—that race and sex have no impact on the pharmacokinetics of Xeloda . 

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