Simulating/predicting outcome of a human bioavailability study from a dissolution test: A simple and practical approach

A method based on convolution technique has been described earlier to predict plasma drug concentration time (C-t) profiles. This article describes further refinement of the method for a more realistic representation of a human bioavailability study outcome by including variabilities in stomach emptying time and bioavailability factor (F). The advantages of such refinement are discussed including setting physiologically relevant specifications for dissolution testing.Please click here for complete article

PS: Please note that an error in the text was detected on page 2, column 2 and paragraph 2, which has been corrected. The revision reads as follows: “For this particular example it is assumed that the filter will release (not adsorb) on average 44%±10(±SD) of the drug, representing average F (bioavailability) and variation in the F for diltiazem.”  My apologies for the oversight and any inconvenience it may have caused. Saeed (July 27, 2012).

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