Predictive conversion of in vitro drug dissolution data into in vivo drug response versus time profiles exemplified for plasma levels of warfarin.

A mathematical approach to computing the in vivo drug response profiles (such as plasma level, pharmacological response, and urinary recovery versus time curves) corresponding to observed in vitro dissolution of drug dosage form versus time profiles is described. The method is exemplified for warfarin tablets,for which observed in vivo plasma level profiles are compared to corresponding predicted profiles computed from in vitro dissolution data. The potential of the method is demonstrated; approaches to its improvement, as well as its limitations, are discussed.